Child ObesityCONNECTNCT02206529
Enhancing Family Based Treatment of Childhood Obesity Through Social Networks
A study testing Social Network Engagement+Std Treatment and Standard Treatment in people with Child Obesity, run by Kaiser Permanente.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Child Obesity
- What is being tested?
- Social Network Engagement+Std Treatment and Standard Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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).
- Conditions
- Child Obesity
- Being tested
- Social Network Engagement+Std Treatment, Standard Treatment
- Keywords
- obesity, child, weight management, behavioral, social networks, social support
- Medical subject headings
- Pediatric Obesity, Obesity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Network Engagement+Std TreatmentBehavioural
Also called SNE
Standard TreatmentBehavioural
Also called FOCUS Intervention
Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Behavioral: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMI Z-score
Measured: 20 weeks after baseline
Child BMI Z-score
Measured: One year post-treatment
Secondary outcomes (4)
Peds QL (child self-report and parent report)
Pediatric Quality of Life Score
Measured: 20 weeks after baseline
Parent BMI
Intervention is aimed at the parent-child dyad, so parent weight status is assessed.
Measured: 20 weeks after baseline
Peds QL (child self-report and parent report)
Pediatric Quality of Life Score
Measured: One year post-treatment
Parent BMI
Intervention is aimed at the parent-child dyad, so parent weight status is assessed.
Measured: One year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Lozano, MD MPH, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206529
- Sponsor's protocol ID
- 211098
- Acronym
- CONNECT
- Status last verified
- Oct 2017
- First submitted
- 21 Jul 2014
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Family Based Treatment of Childhood Obesity Through Social Networks
- ClinicalTrials.gov ID
- NCT02206529
- Acronym / sponsor ID
- CONNECT / 211098
- Conditions
- Child Obesity
- Keywords
- obesity, child, weight management, behavioral, social networks, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Network Engagement+Std Treatment | Active comparator | Behavioral: Social Network Engagement+Std TreatmentSocial 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) |
| Standard Treatment | Other | Behavioral: Standard TreatmentThis 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) |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Network Engagement+Std TreatmentAlso: SNE | Behavioural | Social Network Engagement+Std Treatment |
| Standard TreatmentAlso: FOCUS InterventionStandard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629) | Behavioural | Standard Treatment |
Primary outcome
Child BMI Z-score
Time frame: 20 weeks after baseline
Child BMI Z-score
Time frame: One year post-treatment
4 secondary outcomes
Peds QL (child self-report and parent report)
Time frame: 20 weeks after baseline
Parent BMI
Time frame: 20 weeks after baseline
Peds QL (child self-report and parent report)
Time frame: One year post-treatment
Parent BMI
Time frame: One year post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Lozano, MD MPH principal investigator
Group Health Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Social Network Engagement+Std Treatment and Standard Treatment in people with Child Obesity, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child BMI Z-score (time frame: 20 weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.