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Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

Primary Purpose

Obesity, Childhood

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment

Education plus usual care behavioral treatment

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

10-14 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization. Standard behavioral weight control program eligibility criteria will apply: Both child and at least one parent/guardian must agree to attend sessions.

Exclusion Criteria:

Medical conditions affecting growth - diagnosed with a genetic or metabolic disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy

Medications affecting growth - systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone

Conditions limiting participation in the interventions - e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason

Conditions limiting participation in the assessments - child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language

Unable to read, understand or complete informed consent in English or Spanish

Plan to move from the San Francisco Bay Area within the next 12 months.

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wise interventions plus behavioral Rx

Education plus behavioral Rx

Arm Description

Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care behavioral intervention for weight control.

Health education plus a usual care behavioral intervention for weight control

Outcomes

Primary Outcome Measures

Change in Body Mass Index From Baseline to 6 Months

body mass index = weight in kilograms divided by the squared height in meters

Secondary Outcome Measures

Full Information

NCT ID

NCT04422951

First Posted

June 5, 2020

Last Updated

October 13, 2023

Sponsor

Stanford University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT04422951

Brief Title

Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

Official Title

Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

Delays and complications due to the Covid pandemic

Study Start Date

April 6, 2023 (Actual)

Primary Completion Date

June 20, 2023 (Actual)

Study Completion Date

June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A 2-arm, parallel group, randomized controlled trial to evaluate overall differences in body mass index (BMI) trajectories over 6 months between 10-16-year-old children with obesity randomized to receive the wise social psychological interventions plus a usual care behavioral intervention for weight management compared to children randomized to receive additional education plus a usual care behavioral intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Childhood

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wise interventions plus behavioral Rx

Arm Type

Experimental

Arm Description

Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care behavioral intervention for weight control.

Arm Title

Education plus behavioral Rx

Arm Type

Active Comparator

Arm Description

Health education plus a usual care behavioral intervention for weight control

Intervention Type

Behavioral

Intervention Name(s)

Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment

Intervention Description

Addition of two wise wise social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care behavioral intervention for weight control in children with obesity

Intervention Type

Behavioral

Intervention Name(s)

Education plus usual care behavioral treatment

Intervention Description

6-month health education plus usual care behavioral intervention for weight control in children with obesity

Primary Outcome Measure Information:

Title

Change in Body Mass Index From Baseline to 6 Months

Description

body mass index = weight in kilograms divided by the squared height in meters

Time Frame

Change from baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 10-16 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization. Participation in a behavioral weight control program. Standard behavioral weight control program eligibility criteria will apply: Child and at least one parent/guardian must agree to participate Exclusion Criteria: Medical conditions affecting growth - diagnosed with a genetic or metabolic disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy Medications affecting growth - systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone Conditions limiting participation in the interventions - e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason Conditions limiting participation in the assessments - child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language Unable to read, understand or complete informed consent in English or Spanish

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Robinson, MD, MPH

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data sharing will be based on the policy for data sharing issued by the NIH and consistent with HIPAA privacy standards. Our data management team will prepare de-identified public use data set from this study for deposition in a repository.

IPD Sharing Time Frame

Limited access data will be shared within six months of the publication date for the primary outcome publication or within two years of the date that the database is locked for analysis, whichever occurs first.

IPD Sharing Access Criteria

User registration will be required. Users must agree to the conditions of use governing access to the public release data (a data use agreement), including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.

Learn more about this trial

Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

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