NCT02206529

Brief Summary

The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that will be integrated into a standard treatment program for childhood overweight. The investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its effectiveness compared with historical controls who received standard treatment. The historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

July 21, 2014

Last Update Submit

October 11, 2017

Conditions

Child Obesity

Keywords

obesitychildweight managementbehavioralsocial networkssocial support

Outcome Measures

Primary Outcomes (2)

  • Child BMI Z-score

    20 weeks after baseline

  • Child BMI Z-score

    One year post-treatment

Secondary Outcomes (4)

  • Peds QL (child self-report and parent report)

    20 weeks after baseline

  • Parent BMI

    20 weeks after baseline

  • Peds QL (child self-report and parent report)

    One year post-treatment

  • Parent BMI

    One year post-treatment

Other Outcomes (5)

  • SSQ (Social Support Questionnaire-Short Form)

    20 weeks after baseline

  • QRI (Quality of the Relationship Index)

    20 weeks after baseline

  • SPSI-R (Social Problem-Solving Index-for Research)

    20 weeks after baseline

  • +2 more other outcomes

Study Arms (2)

Social Network Engagement+Std Treatment

ACTIVE COMPARATOR

Social Network Engagement = content and activities to help the parent engage his/her social network in supporting healthy lifestyle behaviors. Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)

Behavioral: Social Network Engagement+Std Treatment

Standard Treatment

OTHER

This comparator arm consists of historical controls, participants in the FOCUS trial who received standard treatment. Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)

Behavioral: Standard Treatment

Interventions

Social Network Engagement+Std TreatmentBEHAVIORAL
Also known as: SNE
Social Network Engagement+Std Treatment
Standard TreatmentBEHAVIORAL

Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)

Also known as: FOCUS Intervention
Standard Treatment

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 7-13 years
  • At or above the 85th percentile for age- and gender-specific BMI
  • Parents
  • At least one overweight parent (BMI\>25.0)
  • Parents and children
  • English-speaking and at least at a second-grade reading level
  • Live \<50 miles from the treatment site.
  • Conditions known to promote obesity (e.g., Prader-Willi),
  • Participation in another weight control program
  • Recently started taking weight-affecting medications (e.g., stimulants).
  • Parents and children
  • Disability or illness that would preclude them from engaging in at least moderate-intensity physical activity,
  • Current or prior diagnosed eating disturbance
  • Thought disorder, suicidality, or substance abuse disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric ObesityObesityBehavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paula Lozano, MD MPH

    Group Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

August 1, 2014

Study Start

May 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2014

Last Updated

October 13, 2017

Record last verified: 2017-10