The prevalence of youth with overweight (body mass index [BMI] ≥ 85th %tile for sex/age) and obesity (BMI ≥ 95th %tile) is a global health concern (1), necessitating clinical interventions to treat obesity through lifestyle modification. The increasing prevalence of obesity is primarily due to decreasing physical activity accompanied by declines in dietary quality and increased energy intake. Clinical interventions through healthier eating and more physical activity demonstrate that improvements in these behaviors are linked to modest positive weight outcomes and improvement in cardiometabolic risk factors (2,3). Consequently, there is rising interest in developing strategies to enhance effectiveness of clinical obesity interventions in adolescents who have the highest rates of obesity (4) and dropout from treatment (5). Targeting both parents and adolescents in weight loss interventions can be an effective approach, but adherence to these programs can be suboptimal (6). Although research suggests that parents of youth with obesity are often facing weight-related issues themselves (6,7), and that parental weight loss is a predictor of child weight loss (8), few studies have examined the effectiveness of engaging the adult caregiver and adolescent in a coordinated weight loss effort. In addition, a growing body of literature suggests that parental weight status predicts child (9), adolescent (10), and adult weight status in offspring (11). Failure to treat the caregiver who can serve as a positive role model for the adolescent (or vice versa) represents a missed opportunity. Adult weight loss is inherently different from adolescent weight loss (12), and pursuing identical approaches with an adolescent could be harmful. As such, a large research gap exists, which can be explored to make adolescent and adult obesity treatment more effective and safer. Although several studies have included families (in supporting roles) in pediatric obesity treatment (13), no studies have examined the impact of coenrolling both adolescent and adult in individually tailored weight loss programs, the feasibility of coordinating these adolescent/adult weight loss efforts, and the effectiveness of coordinated care relative to standard care.
Data suggest that weight interventions in children that involve caregivers are more successful than those not involving parents (14,15). Although programs may differ in format, they generally share a family-based approach in which treatment targets multiple family members, including parents (16). The involvement of parents is grounded in family systems theory (17), which posits that youth health behaviors may be influenced by parenting style, family functioning, and family interactions and emphasizes the importance of emotional support and modeling from parents (17,18). The coenrollment of both adolescents/adults together can help strength communication, emotional support, and accountability, leading to better weight outcomes; these studies are now considered the gold standard approaches to pediatric obesity (18).
Compared with pediatric obesity, the current literature lacks a strong theoretical basis for intervention components in treatment programs for adolescents with obesity. There exist key differences between pediatric and adolescent populations, which may impact on the development and success of family-based interventions. For example, parent–adolescent communication is an important aspect relating to weight as poor communication has been associated with unhealthy weight practices (19). Of the interventions that identify a theoretical basis for intervention strategies, very few explicitly measure the theoretical constructs as potential mediators of program effectiveness. Social cognitive theory and self-determination theory offer constructs relevant to family-based, coordinated obesity treatment for youth and adults (20). Social cognitive theory has served as the basis of several studies targeting weight loss, and its use has been associated with increases in physical activity and healthy eating (21). Similarly, self-determination theory has demonstrated associated benefits with physical activity, healthy eating, and weight outcomes (22,23).
This article describes the study design and conceptual approach of a pilot randomized controlled trial (RCT) to study the feasibility and effectiveness of coenrolling the adolescent and the adult in coordinated, individually tailored and theoretically driven weight loss programs with a strong theoretical basis compared with standard care. On the basis of previous studies showing differential effects on major mediators of weight loss such as dietary intake (24) as well as physical activity (25), as well as effect modification by patient characteristics (26), the primary outcomes of the larger RCT will include detailed measures of dietary intake patterns and physical activity alongside weight status (BMI/BMI z-score). The pilot study will record the previously mentioned outcomes but will primarily focus on feasibility, acceptability, and economic cost of delivery. All data, including structured feedback from participants, will be used to optimize approaches to recruitment, refine the dyad plus curriculum, and increase retention strategies to ultimately increase the efficacy and success of future RCTs testing family-based approaches for weight management among adolescents.
The study is conducted in two weight loss clinics that are part of Wake Forest Baptist Medical Center (WFBMC). The first is Brenner Families in Training (Brenner FIT®), which is an evidence-based program that focuses on treatment of pediatric obesity from ages 2 to 18 yr. The second is the WFBMC Weight Management Center (By Design) that provides adult patients with a range of comprehensive weight management treatment options from medical to surgical interventions. Both Brenner FIT and By Design are programs that use best practices in the field (27,28) and consistently produce clinically meaningful weight loss.
Study Design and Randomization
The study uses a randomized controlled design with three groups: Brenner FIT only; Dyad, where the adolescent and the parent both enroll simultaneously in the age-appropriate program; and Dyad Plus, where the adolescent and the parent both enroll simultaneously in their respective program, but with a coordinated component. The Dyad and the Dyad Plus conditions include all components of Brenner FIT (adolescents) and By Design (adults) for the participants.
Dyads are allocated by our statistician to three groups (n = 15 dyads each) using a fixed allocation randomization procedure and a computer-based random number generating algorithm. Blocked randomization is considered to reduce the chance of between-group imbalances in number of participants and to help protect against temporal trends. Even with blocked randomization, there is no guarantee that all baseline characteristics are equal or similar among study groups. Randomization is stratified by a child’s BMI group (e.g., terciles based on our preliminary data) to protect against imbalance. Data analysis accounts for blocking and stratification as well as relevant factors such as age and sex of the dyad members.
The Brenner FIT clinic is the base of the study and recruitment source. At Brenner FIT, patients are mostly female (58%) and self-identified as White/European American (45%), Black/African American (32%), Hispanic/Latino (18%), or another race (5%). Approximately half of the patient population is in their adolescent years (13–17 yr). Dyads referred to Brenner FIT are eligible for participation if the adolescent under treatment is 13–17 yr old, if they have a caregiver who lives in the home with a BMI > 30, and if neither member of the dyad has a contraindication for physical activity or calorie restriction.
All eligible dyads being treated at Brenner FIT or By Design clinics are asked to participate in the study. Informed consent is sought from each adolescent’s guardian for participation in the interventions and data collection activities. Family members and youth are encouraged to ask any questions they have regarding the procedures. There is no coercion to participate or prejudice against those who choose not to take part in the study. We submitted an application to the WFBMC Institutional Review Board for approval of study procedures and the informed consent protocol. For adolescents, written informed consent from at least one parent/guardian and voluntary written assent is obtained before participation in the study. No data collection takes place before IRB approval or informed parental/adolescent consent/assent.
Condition 1: Brenner FIT Only (Standard Care)
Brenner FIT is an interdisciplinary, family-based pediatric weight management clinic informed by the Familial Approach to Treatment of Childhood Obesity (29–33). Patients are between the ages of 2–18 yr old and referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are composed of a pediatrician, counselor, dietitian, and a physical activity specialist, with others (e.g., social workers and physical therapists) as needed. The entire family is encouraged to attend all aspects of the program, although only one attending caregiver is required. Treatment is guided by an established protocol as is recommended with tertiary care stage 3–4 weight management programs (34). In Brenner FIT, a database ensures treatment progresses within the protocol. After referral, families attend an orientation at which they are scheduled for an introductory 90-min group session that focuses on parents’ role in the intervention; these usually occur within 2–4 wk of orientation. The family then attends a 2-h intake session, where they are seen by the physician, family counselor (LCSW), and activity specialist. After the initial intake sessions, monthly 1-h long visits with the dietitian, counselor, and physical activity specialist are held for 6 months, in which the adolescent and the caregiver see the pediatrician. During the 6 months of the intervention, the adolescent and the caregiver attend four group classes, choosing from topics such as meal planning, physical activity, and parenting. Specialized visits with the physical activity specialist or dietitian are scheduled as pertinent issues arise. Clinic visits with the pediatrician include individualized goal setting (for behaviors family/clinician have agreed to address), healthy eating and physical activity education, and behavioral counseling to implement changes at home. Motivational interviewing, modified by Brenner FIT for use with families (35), is central to the intervention. Family counselors are trained in cognitive behavioral therapy and parenting support and use these approaches to assist families in developing healthy habits. Self-monitoring is part of the intervention as Brenner FIT uses handwritten diet and physical activity logs completed by parents and children. Brenner FIT successfully enrolls a diverse array of families into studies, including those who identify as African American and Latino.
Participants randomized to Brenner FIT receive no additional components except for a Fitbit™ activity tracker. Six additional nutrition and exercise sessions are offered to standardize the number of contact hours across the conditions.
Condition 2: Dyad (Combination of the Two Standard Care Programs)
The Dyad condition is simply coenrollment in the Brenner FIT for the adolescent and By Design for their caregiver. No coordination is made between the two programs for the participants, but each participant is engaged by the staff from the program in which they are enrolled.
Adult participants in the By Design condition will be prescribed the Essentials lifestyle intervention, which includes tailored dietary and physical activity goals designed to achieve 1–2 lb·wk−1 for weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie reduction of 500 kcal·d−1 is prescribed based on estimates of total energy expenditure obtained from a measured resting metabolic rate before enrollment. The minimum calorie prescription is 1200 kcal·d−1. A dietitian provides each participant with a detailed program manual that describes the prescribed diet. The dietitian uses standard behavioral techniques to promote lifestyle behavior changes that enable participants to implement and maintain behaviors necessary to adhere to the dietary prescription. Participants also receive a standard exercise program designed to promote exercise energy expenditure of approximately 600 kcal·wk−1. The exercise prescription includes resistance training for 2 d·wk−1 and aerobic training for 3 d·wk−1, to meet a 600-kcal·wk−1 expenditure goal.
Behaviorists meet with participants to provide individual and group-based counseling to learn the skills necessary to adopt the prescribed diet and exercise plans. Group sessions are delivered consecutively over 6 months (20 total; 1.5 h each), followed by 6 months of bimonthly sessions, then 12 months of monthly sessions. During the initial 6 months (intensive behavior change and weight loss phase), intervention sessions are designed to be participant centered and interactive and include guided physical activity or food demonstration. Participants have individual visits to review treatment goals and overall progress at weeks 0, 12, and 24. Group sessions include behavioral strategies known to support weight loss and lifestyle behavior change, including goal setting, problem solving, and self-monitoring. Key targets in the second year of the intervention include reinforcement messages, self-monitoring, relapse prevention, social support, and problem solving.
Similarly, to those randomized to Brenner FIT, participants enrolled in Dyad receive a Fitbit™ activity tracker. As mentioned above, six additional nutrition and exercise sessions are offered to standardize the number of contact hours across the conditions.
Condition 3: Dyad Plus
Dyad Plus includes all components of the standard Brenner FIT program (adolescents) and By Design (adults) with three additional components: 1) dyad group sessions, 2) one-on-one parent/adolescent communication sessions, and 3) joint goal setting/tracking. This innovative approach seeks to use components of motivation and communication theories to encourage self-monitoring, positive communication, and problem solving. In addition, the approach uses social support to increase healthy physical activity and eating behaviors to improve the effectiveness of the weight loss programs beyond that observed in matched controls (see Fig. 1).
The exact mixture of the sessions depends on the needs of the family, but the dyads are participating in six, 1-h sessions in addition to those required by their weight loss program. Joint goal setting and tracking is enabled by a commercially available device (a Fitbit™ activity tracker) and a custom, mobile enabled Web site. Each caregiver and adolescent receive an activity tracker and access to the Web site designed for self-monitoring of dietary and activity habits and “social accountability,” which allows caregivers and the Brenner FIT team to monitor and encourage. Furthermore, an evaluation of the home food and activity environments is conducted to inform tailored feedback to families.
Physical activity is collected using ActiGraphTM accelerometers. The accelerometers are set to collect data in a raw format and analyzed by converting the data into 1-s epochs to account for the intermittent and sporadic nature of youth physical activity. Monitors are dispersed at baseline (before randomization) and at 6 months (after the intervention phase) for a 7-d data collection period. These monitors are affixed to a strap and worn on the subject’s nondominant wrist. This is a protocol being used in the National Health and Nutrition Examination Survey (36), which has already been successfully used in studies of physical activity. We distill the cut points in a manner consistent with the emerging research in the area and work previously completed that allows for comparability with waist-based estimates. Participants are instructed to wear the monitor continuously over the next 7 d except during bathing and water-based activities consistent with the best practices in community-based data collection.
To assess diet in each participant, the National Cancer Institute’s automated, self-administered 24-h dietary recall, the Automated Self-Administered 24-h (ASA 24®) dietary assessment tool (37), is used on three nonconsecutive days (including one weekend day). Results of the ASA 24® are reported in kilocalories. The ASA 24® is available on both computers and mobile devices. All participants complete one ASA 24® at their baseline orientation and 6-month follow-up visits to encourage compliance while simultaneously allowing youth and caregivers to ask questions and gain comfort using the system. The project coordinator contacts participants when they should complete the second/third dietary recall and offers to conduct the recall over the phone if the youth need assistance. The ASA 24® has been demonstrated to perform equally well as a self-administered or interviewer administered questionnaire (38). A series of follow-up reminder messages and/or phone calls are made by the coordinator to encourage completion for the second/third of the two recalls if not completed within 24 h after the first contact after the clinic visit.
Sociodemographic Variables and Weight Status
Caregiver reported age, sex, race, and ethnicity are collected at the initial visit. Weight status is quantified through BMI derived from measurement of height and weight (BMI = kg / m2) without shoes in normal clothing at the intake visit. Both height (accurate to 0.1 cm) and weight (accurate to 0.5 kg) are recorded twice by a female research assistant, and values are averaged to produce the final value using a digital scale and a stadiometer, respectively.
Family and individual constructs will be assessed to identify potential mediators or moderators of observed effects of the intervention. Brenner FIT uses family systems theory as a guiding model to addressing child and parent behaviors and presently uses several scales to assess families participating in Brenner FIT. Specifically, Brenner FIT families complete the Family Assessment Device General Functioning (capturing family function) and communication subscales, perceived stress, self-efficacy for physical activity, behavioral self-regulation, and health behaviors of the family.
In addition, the team administers scales to capture social cognitive theory and self-determination theory constructs targeted by the intervention that are not captured as part of the intake process. These include outcome expectations, autonomy, autonomy support, and relatedness (39). All psychosocial data are collected at baseline (before randomization), 3 months, and 6 months.
Economic Costs of Delivery
The costs associated with implementing the three conditions are collected over the duration of the program. These costs allow the calculation of the full economic cost of delivering each condition, which includes both direct and indirect as well as opportunity costs. Examples include supplies and materials utilization (e.g., printing of materials for participants), training costs (e.g., hourly wages for employees), costs associated with actual delivery of the coordinated sessions, and opportunity costs (e.g., volunteer time, donated materials). Economic costs of implementing these three conditions are compared to identify the most cost-efficient condition. Costs related to the evaluation of these strategies/conditions are excluded to capture the true economic cost of replicating the strategies across other clinics.
Fasting Serum biomarkers
Cardiometabolic markers are collected at baseline and 6 months to examine for any changes. The markers collected include fasting glucose, fasting insulin level, hemoglobin A1c, aspartate aminotransferase level, alanine aminotransferase level, and total cholesterol. These markers can identify physiological changes related to obesity such as fatty liver disease, diabetes, and hyperlipidemia, which have large, long-term health implications.
Feasibility is assessed consistent with the recommendations of Leon and colleagues (40). Specifically, screening, recruitment, randomization, retention, adherence, fidelity, and the assessment process are all examined. The number of patients screened per month, the number enrolled per month, the proportion that are eligible who enroll, and the intervention participation remain enrolled in the study by condition is tracked. Retention (completion of at least 75% of monthly sessions through 6 months) is tracked for each intervention condition. Adherence to the intervention protocol by the participants is measured using a computer-aided tracking system. Finally, the time needed for assessments and gathering feedback on participant burden is monitored.
Acceptability is assessed both qualitatively and quantitatively with open-ended questions at posttest, tracking of attendance at required sessions, and compliance with self-monitoring. A brief survey is used for caregivers and youth to gain insight into their perception of the Dyad Plus components after completion of the 6-month assessments (i.e., completion of the study). Surveys include the System Usability Scale (41) to inquire about the usability of the tracking apps, Fitbit tracking device, and session format and content.
Intervention groups are compared on baseline characteristics, including psychosocial, behavioral, and anthropometric measures using statistical procedures determined by type of measure and distribution (e.g., nominal, ordinal, ranked, discrete, and continuous). Outlying values are checked for plausibility and thorough logical and statistical checks. Measures with skewed distributions are considered for statistical transformation and robust estimation.
Procedures for preventing and monitoring missing data are implemented whenever possible, and patterns of observed data are taken into account in selection of analysis methods. For methods with unverifiable assumptions, sensitivity analyses are conducted. Analysis covariates (e.g., parent/adolescent age, sex, and baseline pre/diabetes status) are selected a priori. Statistical significance will be denoted by two-tailed P values <0.05 and 95% confidence intervals (CI).
Aim 1: Develop a Coordinated Intervention for Adolescents and Adults with Obesity Coenrolled in Brenner FIT and By Design Weight Loss Clinics
No formal hypothesis testing is conducted in aim 1; however, perceptions are collected, including on the four novel components: 1) dyad group sessions, 2) one-on-one parent/adolescent communication sessions, 3) joint goal setting/tracking, and 4) home environment assessment. We anticipate reaching high perceived acceptability and a corresponding increase in the likelihood of a smooth transition to the pilot trial.
Aim 2: Pilot the Coordinated Intervention in Adolescent/Caregiver Dyads to Establish the Feasibility of the Intervention in Terms of Accrual, Retention, and Adherence
The goal of aim 2 is to test the hypothesis that retention will be at least 75% in each intervention group. Within-group retention in the pilot trial is calculated as the percentage of dyads within the intervention group completing at least 75% of monthly sessions through 6 months. For inclusion in this definition, one measure is selected a priori among each category of outcome (psychosocial, behavioral, and anthropometric). An intention-to-treat analysis is followed. Two-tailed 95% Wilson CI values for unknown proportions are calculated for retention in each group.
Aim 3: Establish the Costs Associated with the Implementation of Dyad Plus Relative to Delivering By Design and Brenner FIT without the Coordination Component
Economic costs of delivery (i.e., resource use) associated with implementing the three conditions are collected over the duration of the program. These costs allow the calculation of the full economic cost of delivering each condition, which includes both direct and indirect as well as opportunity costs. Examples of these include supplies and materials utilization (e.g., printing of materials for participants), training costs (e.g., hourly wages for employees), costs associated with actual delivery of the mHealth components, and opportunity costs (e.g., volunteer time and donated materials). Net costs associated with delivering the strategies are calculated by subtracting the costs for Brenner FIT from the costs of the two additional conditions. Costs related to the evaluation of these strategies/conditions are excluded to capture the true economic cost of replicating the strategies across other clinics. One way to express cost is cost per adolescent enrolled. The more money caregivers pay for enrollment, the lower the likelihood of participation, especially when patients are from lower socioeconomic categories. For the proposed study, there are no additional costs for participants beyond those associated with the standard Brenner FIT program (e.g., copays).
Trial Sample Size and Precision of Estimates
Given a sample size n = 15 (each group), we anticipate a range of possible precision for our retention probability estimates (CI) as follows: a true probability of 0.6 yields a median (and approximate mean) 95% CI length of 0.44 (approximate first and third quartile lengths ±0.01); for 0.9, this is 0.29 ± 0.06. The observed CI values provide a plausible range for the true retention in our population and trial conditions. If the CI excludes values <0.75, we declare acceptable retention to plan a large-scale trial of Dyad Plus; regardless, these estimates (CI) are weighed heavily, and together with many other components of the trial experience, to determine overall acceptability and feasibility and to help assist with design aspects of any future trial.
Longitudinal data analysis is conducted, including for estimation of weight loss. Although not primary outcomes of the pilot trial, these intervention effects (Dyad Plus vs. Dyad, and Dyad Plus vs. Brenner FIT) and the variability estimates, together with additional estimates from the pilot trial, will be important for the design of a future trial. This includes estimates of accrual, ineligibility by reason, retention, completeness of data, and adherence to interventions.
Despite a large body of literature on adult and pediatric weight loss, including family-based treatment, studies have been less successful in creating or implementing effective strategies for weight loss in adolescents. There are very few studies that target adolescents with a comprehensive behavior intervention as outlined in this current study. Although the concept of coordinated intervention has been explored, the results produced by the few studies to attempt a coordinated treatment plan have been promising in some cases and paradoxical in others. This will be the first study to develop a coordinated adolescent/caregiver weight loss intervention grounded in communication, family systems, and motivational theory.
The current study substantially departs from previous studies by creating a joint weight loss program with a comonitoring component between caregiver/adolescent that is backed by a strong theoretical foundation. Furthermore, the study focuses on the safety of the adolescent patient by not involving them in programs designed for adults that focus on restrictive behaviors that are potentially harmful. The outcomes from this study can help provide evidence regarding the feasibility, acceptability, and effectiveness of a coordinated model relative to standard care and lead to a larger trial studying weight loss outcome data.
In this article, we describe the design and conceptual approach of a coordinated care model between adolescent and caregivers with overweight or obesity and assess the feasibility, acceptability, and effectiveness of the coordinated model relative to standard care of enrolling solely the adolescent in treatment. The proposed project has considerable translational potential, as adult and pediatric obesity treatment programs coexist in most academic medical centers. The proposed research will inform a proposal to test the effectiveness of a coordinated versus an uncoordinated approach and will allow us to examine 6-month adherence and weight loss outcome data to inform sample size calculations and generate estimates of variability for a larger trial.
The research reported in this publication was supported by the National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) under award number R21HD101036. The project described was supported by the National Center for Advancing Translational Sciences (NCATS), NIH, through Grant Award Number UL1TR001420. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the American College of Sports Medicine. This study is registered in ClinicalTrials.gov as NCT04036331.
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