Trial Outcomes & Findings for Guided Self-help for Families With an Overweight Child (NCT NCT01145833)

NCT ID: NCT01145833

Last Updated: 2020-09-03

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

5 months

Results posted on

2020-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate Treatment Group The immediate treatment group begins the 5-month treatment immediately after baseline assessment.	Delayed Treatment Group The delayed treatment group serves as the control group.
Overall Study STARTED	25	25
Overall Study COMPLETED	22	25
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Guided Self-help for Families With an Overweight Child

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Treatment Group n=25 Participants The immediate treatment group begins the 5-month treatment immediately after baseline assessment.	Delayed Treatment Group n=25 Participants The delayed treatment group serves as the control group.	Total n=50 Participants Total of all reporting groups
Age, Continuous	10.3 years STANDARD_DEVIATION 1.3 • n=39 Participants	10.5 years STANDARD_DEVIATION 1.4 • n=41 Participants	10.4 years STANDARD_DEVIATION 1.35 • n=35 Participants
Sex: Female, Male Female	15 Participants n=39 Participants	16 Participants n=41 Participants	31 Participants n=35 Participants
Sex: Female, Male Male	10 Participants n=39 Participants	9 Participants n=41 Participants	19 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=39 Participants	4 Participants n=41 Participants	7 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=39 Participants	21 Participants n=41 Participants	43 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants	3 Participants n=41 Participants	4 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Black or African American	2 Participants n=39 Participants	1 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) White	21 Participants n=39 Participants	21 Participants n=41 Participants	42 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	25 participants n=39 Participants	25 participants n=41 Participants	50 participants n=35 Participants
Child BMI	24.1 kg/m^2 STANDARD_DEVIATION 1.9 • n=39 Participants	24.4 kg/m^2 STANDARD_DEVIATION 2.6 • n=41 Participants	24.2 kg/m^2 STANDARD_DEVIATION 2.3 • n=35 Participants
Parent BMI	27.5 kg/m^2 STANDARD_DEVIATION 6.1 • n=39 Participants	27.9 kg/m^2 STANDARD_DEVIATION 6.1 • n=41 Participants	27.7 kg/m^2 STANDARD_DEVIATION 6.1 • n=35 Participants

PRIMARY outcome

Timeframe: 5 months

Outcome measures

Outcome measures
Measure	Immediate Treatment Group n=22 Participants The immediate treatment group begins the 5-month treatment immediately after baseline assessment.	Delayed Treatment Group n=25 Participants The delayed treatment group serves as the control group.
Child BMI	23.3 kg/m^2 Standard Deviation 2.1	25.17 kg/m^2 Standard Deviation 2.79

SECONDARY outcome

Timeframe: 5 months

Outcome measures

Outcome measures
Measure	Immediate Treatment Group n=22 Participants The immediate treatment group begins the 5-month treatment immediately after baseline assessment.	Delayed Treatment Group n=25 Participants The delayed treatment group serves as the control group.
Parent BMI	26.8 kg/m^2 Standard Deviation 6.4	28.0 kg/m^2 Standard Deviation 6.2

Adverse Events

Immediate Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Treatment Group

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

Kerri Boutelle, Principal Investigator

University of CA, San Diego Center for Healthy Eating and Activity Research

Phone: 858-534-8037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place