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The Role of Parents in Adolescent Weight Loss

Primary Purpose

Adolescent Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Weight Control with Enhanced Parent Involvement
Behavioral Weight Control with Minimal Parent Involvement
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Obesity

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 30 and 90% overweight
  • Parent or guardian willing to participate

Exclusion Criteria:

  • Major psychiatric disorder

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Behavioral Weight Control with Enhanced Parent Involvement

Behavioral Weight Control with Minimal Parent Involvement

Arm Description

This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.

This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.

Outcomes

Primary Outcome Measures

Body Mass Index
Post-treatment BMI (controlling for baseline BMI)

Secondary Outcome Measures

Parent Modeling 1: Dietary Choices (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.
Parent Modeling 2: Self-monitoring (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.
Parent Modeling 3: Physical Activity (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.
Parent Modeling 4: Weight and Body Concerns (FERF-Q)
Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.
Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)
Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.
Communication 2: Observed Parent-adolescent Communication Quality (DOCS)
Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.

Full Information

First Posted
June 7, 2010
Last Updated
August 8, 2016
Sponsor
The Miriam Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01139411
Brief Title
The Role of Parents in Adolescent Weight Loss
Official Title
Parental Involvement as a Strategy to Enhance Adolescent Weight Control
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine whether a novel model of including parents in adolescent weight control results in greater decrease in adolescent z-BMI compared to an intervention with minimal parent involvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Weight Control with Enhanced Parent Involvement
Arm Type
Experimental
Arm Description
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Arm Title
Behavioral Weight Control with Minimal Parent Involvement
Arm Type
Placebo Comparator
Arm Description
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Weight Control with Enhanced Parent Involvement
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Weight Control with Minimal Parent Involvement
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Post-treatment BMI (controlling for baseline BMI)
Time Frame
Baseline and at completion of 16 week intervention
Secondary Outcome Measure Information:
Title
Parent Modeling 1: Dietary Choices (WCSS)
Description
Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.
Time Frame
Baseline to post-treatment
Title
Parent Modeling 2: Self-monitoring (WCSS)
Description
Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.
Time Frame
Baseline to post-treatment
Title
Parent Modeling 3: Physical Activity (WCSS)
Description
Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.
Time Frame
Baseline to post-treatment
Title
Parent Modeling 4: Weight and Body Concerns (FERF-Q)
Description
Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.
Time Frame
Baseline to post-treatment
Title
Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)
Description
Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.
Time Frame
Baseline to post-treatment
Title
Communication 2: Observed Parent-adolescent Communication Quality (DOCS)
Description
Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.
Time Frame
Baseline to post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 30 and 90% overweight Parent or guardian willing to participate Exclusion Criteria: Major psychiatric disorder
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

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The Role of Parents in Adolescent Weight Loss

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