The Role of Parents in Adolescent Weight Loss

NCT01139411 | Completed Results DMC

• 2 other identifiers: GRANT00538804R03HD060137
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Obesity

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  Post-treatment BMI (controlling for baseline BMI)

  Baseline and at completion of 16 week intervention

Secondary Outcomes (6)

• Parent Modeling 1: Dietary Choices (WCSS)

  Baseline to post-treatment

• Parent Modeling 2: Self-monitoring (WCSS)

  Baseline to post-treatment

• Parent Modeling 3: Physical Activity (WCSS)

  Baseline to post-treatment

• Parent Modeling 4: Weight and Body Concerns (FERF-Q)

  Baseline to post-treatment

• Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)

  Baseline to post-treatment

Study Arms (2)

Behavioral Weight Control with Enhanced Parent Involvement

EXPERIMENTAL

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

Behavioral Weight Control with Minimal Parent Involvement

PLACEBO COMPARATOR

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

Behavioral: Behavioral Weight Control with Minimal Parent Involvement

Interventions

Behavioral Weight Control with Enhanced Parent Involvement BEHAVIORAL

Behavioral Weight Control with Enhanced Parent Involvement

Behavioral Weight Control with Minimal Parent Involvement BEHAVIORAL

Behavioral Weight Control with Minimal Parent Involvement

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Major psychiatric disorder

Sponsors & Collaborators

• The Miriam Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Elissa Jelalian
• Organization: Weight Control and Diabetes Research Center

elissa_jelalian@brown.edu

(401) 793-9716

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 8, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: September 30, 2016
• Results First Posted: September 30, 2016

Record last verified: 2016-08

Locations

US (1)