The Role of Parents in Adolescent Weight Loss

• ClinicalTrials.gov Identifier: NCT01139411
• Recruitment Status: Completed
• First Posted: June 8, 2010
• Results First Posted: September 30, 2016
• Last Update Posted: September 30, 2016
• Sponsor: The Miriam Hospital
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Elissa Jelalian, The Miriam Hospital

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.

Condition or disease	Intervention/treatment	Phase
Adolescent Obesity	Behavioral: Behavioral Weight Control with Enhanced Parent Involvement; Behavioral: Behavioral Weight Control with Minimal Parent Involvement	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Parental Involvement as a Strategy to Enhance Adolescent Weight Control
• Study Start Date: August 2009
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

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.	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

Outcome Measures

Primary Outcome Measures :

1. Body Mass Index [ Time Frame: Baseline and at completion of 16 week intervention ]
   Post-treatment BMI (controlling for baseline BMI)

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: GRANT00538804; R03HD060137 ( U.S. NIH Grant/Contract )
• First Posted: June 8, 2010
• Results First Posted: September 30, 2016
• Last Update Posted: September 30, 2016
• Last Verified: August 2016

Additional relevant MeSH terms:

Pediatric Obesity; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight