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

NCT ID: NCT04422951

Last Updated: 2023-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2023-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Wise interventions plus behavioral Rx

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Education plus behavioral Rx

Health education plus a usual care behavioral intervention for weight control

Group Type ACTIVE_COMPARATOR

Education plus usual care behavioral treatment

Intervention Type BEHAVIORAL

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

Interventions

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

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

Education plus usual care behavioral treatment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Robinson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Robinson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R01DK123286

Identifier Type: NIH

Identifier Source: secondary_id

View Link

54341

Identifier Type: -

Identifier Source: org_study_id

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