Parent Involvement in Adolescent Obesity Treatment

Study Overview
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Brief Summary
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A randomized control trial to compare the efficacy of two distinct parent treatments on weight loss maintenance for adolescents with obesity participating in a lifestyle intervention including nutrition education, exercise and behavioral support. Funding support from NIH via 1R01HD095910

Detailed Description
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Investigators will recruit adolescents with overweight or obesity (BMI>85th percentile) and a parent (BMI > 25 kg/m2). Families will participate in one of two 4-month treatments: 1) TEENS+ Parents as Coaches (PAC), engaging parents as helpers in their child's weight management, or 2) TEENS+ Parent Weight Loss (PWL), engaging parents in their own weight management. All adolescents will participate in TEENS+, which includes behavioral support, nutrition education, and supervised physical activity. For adolescents, the intervention will consist of weekly behavioral weight management group sessions and weekly 1 hour exercise sessions. Each adolescent also has a monthly individual session with a behavior coach. Parent groups meet weekly for 1 hour according to treatment arm (PAC or PWL). All PWL sessions are separate from their adolescent. Bi-weekly sessions in the PAC arm are combined with parents and adolescent. Assessments will consist of anthropometric measures, psychological surveys and dietary and PA evaluations. Assessments will be completed at baseline, 2 months, 4 months (post-test), 8 months and 1 year.

Official Title
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The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: TEENS+Parents as Coaches
* Behavioral: TEENS+Parent Weight Loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent Inclusion Criteria: BMI ≥ 85th percentile for age and gender according to the CDC Growth Charts Age 12 to 16 Must reside with the primary participating parent Parent Inclusion Criteria: ≥18 BMI ≥ 25 kg/m2 Must reside with the adolescent Exclusion Criteria: Adolescent Exclusion Criteria: Non-English speaking Medical condition(s) that may be associated with unintentional weight change Diabetes mellitus Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation Use of a GLP-1 within 6 months of study participation Use of Depo-Provera within 6 months of study participation Medical condition(s) that may be negatively impacted by exercise Psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity Reports of compensatory behaviors in the past 3 months Current pregnancy or plan to become pregnant during study period Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304 Current participation in another weight loss program Personal history of weight loss surgery Severe depression Clinically significant eating disorder Change in dose of metformin, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation Admission to a psychiatric hospital within the past year Parent Exclusion Criteria: Non-English speaking Medical condition(s) that may be associated with unintentional weight change Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation Use of a GLP-1 within 6 months of study participation with no T2D diagnosis; if T2D diagnosis, change in dose GLP-1 within 3 months of study participation Use of Depo-Provera within 6 months of study participation Psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity Reports of compensatory behaviors in the past 3 months Current pregnancy, lactation, less than 6 months post-partum, or plan to become pregnant during study period Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304 Current participation in another weight loss program Personal history of weight loss surgery Severe depression Clinically significant eating disorder Change in dose of diabetes medications, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation Admission to a psychiatric hospital within the past year

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TEENS+Parents as Coaches<br>Parents are taught strategies to support and facilitate child weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on strategies to facilitate healthy weight management in their child(ren). Topics include role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. They receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents will receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. | Behavioral: TEENS+Parents as Coaches<br>* Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.<br>* Other names: Parents as Champions for TEENS (PACT);|
| Active Comparator: TEENS+Parent Weight Loss<br>Parents are given a weight loss goal of 1-2 lbs/week, and specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. | Behavioral: TEENS+Parent Weight Loss<br>* Parent Weight loss teaches core behavioral weight loss strategies and techniques for parent weight loss; adolescents are in a group based behavioral weight management treatment.<br>* Other names: Healthy You!;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent weight loss maintenance | Primary pre-specified outcome is BMI change (kg/m2; adolescent) during the maintenance phase. At 0, 2, 4, 8, 12 months, trained staff will measure adolescent height and weight (in light clothing and after a 12 hour fast) to the nearest 0.1cm and 0.1kg using a precision stadiometer and digital scale, respectively. BMI will be calculated (kg/m2); Adolescent BMI Z-scores will be determined using Epi Info software. | 8 months [4 month - 12 month follow up] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent weight loss | trained staff will measure parent height and weight (in light clothing and after a 12 hour fast) to the nearest 0.1cm and 0.1kg using a precision stadiometer and digital scale, respectively, at 0, 2, 4, 8, 12 months. Percent weight loss and weight change (kg) from baseline to 4 months is the primary parent weight loss outcome interval. | 4 months [0 - 4 month] | 
| Physical activity | Accelerometers will be worn for 1 week by adolescents and parents for each assessment period (0, 4, 8, and 12 months) to assess adolescent and parent physical activity objectively. Total time (min/wk) spent in moderate/vigorous activity and mean total daily physical activity energy expenditure (kcal/d) estimated via accelerometer will be examined. The Seven-Day Physical Activity Recall (PAR) will also be administered to participants in person at the same timepoints. This measure asks them to report the approximate number of hours they slept and engaged in moderate, hard and very hard activity for each day of the preceding week. Parent and adolescent change in physical activity from 4-12 months during the maintenance period is the primary PA outcome. | 8 months [4 months - 12 months] | 
| Dietary intake | Adolescent and parent participants will complete a 3-day food record to track dietary intake for 2 weekdays and 1 weekend day in the week prior to their assessment (0, 4, 8, 12m). Parent and adolescent average total energy intake (kcal/d) from 4-12 months will be the primary dietary outcome. | 8 months [4 months - 12 months] | 
| Parenting Style | The Authoritative Parenting Index (API) will assess adolescent-report of authoritative parenting style and the Parenting Styles and Dimension Questionnaire (PSDQ) will be administered to parents to assess parent self-report of parenting style. Both measures will be administered at 0, 2, 4, 8, 12 months. | 4 months [0-4 month] | 
| Role Modeling | At 0, 2, 4, 8, 12 months, adolescents will complete the Family Experiences Related to Food Questionnaire (FERFQ) is an 8 or 9-item measure (father and mother version, respectively) that will assess family commentary about weight and shape as well as family modeling of diet and weight concerns. | 4 months [0-4 month] | 
| Child Feeding | At 0, 2, 4, 8, 12 months, parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess parent feeding style, | 4 months [0-4 month] | 
| Home Environment | The Home Food Inventory (HFI) and Exercise Environment Questionnaire (EEQ) will assess availability of types of food or exercise equipment, respectively, in the home. Measures will be completed at 0, 2, 4, 8, 12 months. | 4 months [0-4 month] | 
| Weight control practices | Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) which will assess the use of healthy weight control practices (e.g., dietary choices, self-monitoring, and physical activity) at 0, 2, 4, 8, 12 months. | 12 months [0-4 mo; 4-12 mo] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Obesity, Lifestyle Intervention, Family-based Intervention, Motivational Interviewing