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

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Stanford University

Status

Terminated

Conditions

Obesity, Childhood

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04422951
R01DK123286 (U.S. NIH Grant/Contract)
54341

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

10 to 16 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

2 participants in 2 patient groups

Wise interventions plus behavioral Rx
Experimental group
Description:
Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care behavioral intervention for weight control.
Treatment:
Behavioral: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment
Education plus behavioral Rx
Active Comparator group
Description:
Health education plus a usual care behavioral intervention for weight control
Treatment:
Behavioral: Education plus usual care behavioral treatment

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Thomas Robinson, MD, MPH

Data sourced from clinicaltrials.gov

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