- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01139411
The Role of Parents in Adolescent Weight Loss
August 8, 2016 updated by: Elissa Jelalian, The Miriam Hospital
Parental Involvement as a Strategy to Enhance Adolescent Weight Control
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- The Miriam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 30 and 90% overweight
- Parent or guardian willing to participate
Exclusion Criteria:
- Major psychiatric disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral Weight Control with Enhanced Parent Involvement
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
|
|
|
Placebo Comparator: Behavioral Weight Control with Minimal Parent Involvement
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: Baseline and at completion of 16 week intervention
|
Post-treatment BMI (controlling for baseline BMI)
|
Baseline and at completion of 16 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Modeling 1: Dietary Choices (WCSS)
Time Frame: Baseline to post-treatment
|
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.
|
Baseline to post-treatment
|
|
Parent Modeling 2: Self-monitoring (WCSS)
Time Frame: Baseline to post-treatment
|
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.
|
Baseline to post-treatment
|
|
Parent Modeling 3: Physical Activity (WCSS)
Time Frame: Baseline to post-treatment
|
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.
|
Baseline to post-treatment
|
|
Parent Modeling 4: Weight and Body Concerns (FERF-Q)
Time Frame: Baseline to post-treatment
|
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.
|
Baseline to post-treatment
|
|
Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)
Time Frame: Baseline to post-treatment
|
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.
|
Baseline to post-treatment
|
|
Communication 2: Observed Parent-adolescent Communication Quality (DOCS)
Time Frame: Baseline to post-treatment
|
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.
|
Baseline to post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
June 7, 2010
First Submitted That Met QC Criteria
June 7, 2010
First Posted (Estimate)
June 8, 2010
Study Record Updates
Last Update Posted (Estimate)
September 30, 2016
Last Update Submitted That Met QC Criteria
August 8, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRANT00538804
- R03HD060137 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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