Trial Outcomes & Findings for Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity (NCT NCT04422951)

NCT ID: NCT04422951

Last Updated: 2023-10-16

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

Change from baseline to 6 months

Results posted on

2023-10-16

Participant Flow

To enter the study, the child and at least one parent/guardian must have agreed to participate, and both child and adult were considered to be enrolled.

Participant milestones

Participant milestones
Measure	Wise Interventions Plus Behavioral Rx Participants receive Wise social psychological interventions (growth mindset and values self-affirmation) plus a 6-month usual care behavioral intervention for weight control.	Education Plus Behavioral Rx Participants receive health education plus a 6-month usual care behavioral intervention for weight control.
Overall Study STARTED	0	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Education Plus Behavioral Rx n=2 Participants Participants receive health education plus a 6-month usual care behavioral intervention for weight control.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 6 months

Population: No participant had post-baseline BMI data

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

Outcome measures

Outcome data not reported

Adverse Events

Education Plus Behavioral Rx

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas N. Robinson, MD, MPH

Stanford University

Phone: (650) 723-5331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place