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

NCT04422951 | Terminated Results

• 2 other identifiers: 54341R01DK123286
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index From Baseline to 6 Months

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

  Change from baseline to 6 months

Study Arms (2)

Wise interventions plus behavioral Rx

EXPERIMENTAL

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

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

Education plus behavioral Rx

ACTIVE COMPARATOR

Health education plus a usual care behavioral intervention for weight control

Behavioral: Education plus usual care behavioral treatment

Interventions

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

Wise interventions plus behavioral Rx

Education plus usual care behavioral treatment BEHAVIORAL

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

Education plus behavioral Rx

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

This study did not meet its planned enrollment and did not achieve statistical power.

Results Point of Contact

• Title: Thomas N. Robinson, MD, MPH
• Organization: Stanford University

tom.robinson@stanford.edu

(650) 723-5331

Study Officials

• Thomas Robinson, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: April 6, 2023
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: October 16, 2023
• Results First Posted: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)