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The Role of Parents in Adolescent Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Elissa Jelalian, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01139411
First received: June 7, 2010
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Adolescent Obesity
Behavioral: Behavioral Weight Control with Enhanced Parent Involvement
Behavioral: Behavioral Weight Control with Minimal Parent Involvement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Parental Involvement as a Strategy to Enhance Adolescent Weight Control

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: Baseline and at completion of 16 week intervention ] [ Designated as safety issue: No ]
    Post-treatment BMI (controlling for baseline BMI)


Secondary Outcome Measures:
  • Parent Modeling 1: Dietary Choices (WCSS) [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: August 2009
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Behavioral Weight Control with Enhanced Parent Involvement
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.
Behavioral: Behavioral Weight Control with Minimal Parent Involvement

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major psychiatric disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139411

Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Responsible Party: Elissa Jelalian, Senior Scientist, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01139411     History of Changes
Other Study ID Numbers: GRANT00538804  R03HD060137 
Study First Received: June 7, 2010
Results First Received: June 20, 2016
Last Updated: August 8, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on December 05, 2016