Parent Involvement in Adolescent Obesity Treatment

Pediatric Obesity Clinical Trial

— TEENS+  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03851796
• Other study ID #: HM20014304
• Secondary ID: R01HD095910-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 418
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• TEENS+Parents as Coaches
Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.
• TEENS+Parent Weight Loss
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond at VCU Healthy Lifestyles Center	Henrico	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of North Carolina, University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Autonomy Support	At 0, 2, 4, 8, 12 months, adolescents will complete the Perceived Parental Autonomy Support Scale (P-PASS) to assess adolescent perception of 1) autonomy-supportive parenting behaviors and 2) controlling parenting behaviors.	4 months [0-4 month]
Other	Parent Child Relationship	The Conflict Behavior Questionnaire (CBQ; Parent and Adolescent Versions) will assess parent and adolescent report of parent-child relational factors at 0, 2, 4, 8, 12 mo.	4 months [0-4 month]
Other	Parent Self-efficacy	The Parent Efficacy for Child Healthy Weight Behavior (PECHWB) will assess parent self-efficacy in promoting healthy weight behaviors in their adolescents. This measure will be completed at 0, 2, 4, 8, 12 months.	4 months [0-4 month]
Other	Social Support	At 0, 2, 4, 8, 12 months, adolescents will complete family and friend social support scales from the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE+) questionnaires to assess adolescent report of family and friend social support across 3 domains: 1) fruit and vegetable intake, 2) fat intake, and 3) physical activity	4 months [0-4 month]
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]