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Completed

NCT Number: NCT02206529

Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

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).

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Key information

Conditions

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

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children

  • 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.

Exclusion Children

  • 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

Treatment and study plan

Social Network Engagement+Std Treatment

Behavioral

Other names: SNE

Standard treatment

Behavioral

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

Other names: FOCUS Intervention

Primary outcomes

  1. Child BMI Z-score

    Time frame: 20 weeks after baseline

  2. Child BMI Z-score

    Time frame: One year post-treatment

Secondary outcomes

  1. Peds QL (child self-report and parent report)

    Time frame: 20 weeks after baseline

    Pediatric Quality of Life Score

  2. Parent BMI

    Time frame: 20 weeks after baseline

    Intervention is aimed at the parent-child dyad, so parent weight status is assessed.

  3. Peds QL (child self-report and parent report)

    Time frame: One year post-treatment

    Pediatric Quality of Life Score

  4. Parent BMI

    Time frame: One year post-treatment

    Intervention is aimed at the parent-child dyad, so parent weight status is assessed.

Other outcomes

  1. SSQ (Social Support Questionnaire-Short Form)

    Time frame: 20 weeks after baseline

    Global social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.

  2. QRI (Quality of the Relationship Index)

    Time frame: 20 weeks after baseline

    Relationship-specific social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.

  3. SPSI-R (Social Problem-Solving Index-for Research)

    Time frame: 20 weeks after baseline

    Measure of parental skill in problem-solving, assessed as possible mediator of effect of intervention on primary and secondary outcomes.

  4. Behavioral Skill Assessment

    Time frame: 20 weeks after baseline

    Process measure of parental use of skills taught during intervention

  5. WMSI (Weight Management Support Index)

    Time frame: 20 weeks after baseline

    Measure of parental perceived social support related to weight management, assessed as possible mediator of primary and secondary outcomes.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Acronym: CONNECT

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 1, 2014
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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