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Clinical Trials/NCT03851796
NCT03851796
Completed
N/A

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

Virginia Commonwealth University1 site in 1 country418 target enrollmentMay 23, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
Virginia Commonwealth University
Enrollment
418
Locations
1
Primary Endpoint
Body Mass Index (BMI) Change
Status
Completed
Last Updated
4 months ago

Overview

Brief 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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 23, 2019
End Date
October 26, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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:
  • 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

Outcomes

Primary Outcomes

Body Mass Index (BMI) Change

Time Frame: 4 months to 12 month [follow up phase]

Body Mass Index (BMI) change (kg/m2; adolescent) during the maintenance phase (4-month to 12-month).

Body Mass Index

Time Frame: Baseline, 2-, 4-, 8-, and 12-months

National Health and Nutrition Examination Survey (NHANES) Anthropometry methods were used to measure height and weight to calculate Body Mass Index (BMI). At 0, 2, 4, 8, 12 months, trained staff measured 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.

Secondary Outcomes

  • Physical Activity Energy Expenditure Change(4-month to 12-month)
  • Dietary Intake(Baseline, 4-, 8-, and 12-months)
  • Home Food Environment(Baseline, 2-, 4-, 8-, and 12-months)
  • Parent Weight(Baseline, 2-, 4-, 8-, and 12-months)
  • Parent Weight Change(baseline to 4 month [intervention phase] and 4 month to 12 month [maintenance phase])
  • Physical Activity(Baseline, 4-, 8-, and 12-months)
  • Physical Activity Change(4-month to 12-month)
  • Physical Activity Energy Expenditure(Baseline, 4-, 8-, and 12-months)
  • Parent Reported Parenting Style(Baseline, 2-, 4-, 8-, and 12-months)
  • Role Modeling(Baseline, 2-, 4-, 8-, and 12-months)
  • Restrictive Child Feeding Practices(Baseline, 2-, 4-, 8-, and 12-months)
  • Overall Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
  • Self Monitoring Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
  • Dietary Choices Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
  • Physical Activity Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
  • Psychological Coping Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
  • Adolescent Reported Responsiveness Parenting Style(Baseline, 2-, 4-, 8-, and 12-months)
  • Adolescent Reported Demandingness Parenting Style(Baseline, 2-, 4-, 8-, and 12-months)
  • Adolescent Reported Authoritative Parenting Style(Baseline, 2-, 4-, 8-, and 12-months)
  • Home Exercise Environment(Baseline, 4-, 8-, and 12-months)
  • Monitoring Child Feeding Practices(Baseline, 2-, 4-, 8-, and 12-months)

Study Sites (1)

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