Trial Outcomes & Findings for A Primary Care Behavioral Approach for Addressing Childhood Overweight (NCT NCT00284557)
NCT ID: NCT00284557
Last Updated: 2012-07-11
Results Overview
The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
6-months post-intervention
Results posted on
2012-07-11
Participant Flow
Participant milestones
| Measure |
Group-based Behavioral Intervention
The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
|
Health Education Materials Only
Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
63
|
|
Overall Study
COMPLETED
|
58
|
50
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Primary Care Behavioral Approach for Addressing Childhood Overweight
Baseline characteristics by cohort
| Measure |
Group-based Behavioral Intervention
n=67 Participants
The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
|
Health Education Materials Only
n=63 Participants
Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
67 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
9.5 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
9.3 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
9.4 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
63 participants
n=7 Participants
|
130 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-months post-interventionThe body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
Outcome measures
| Measure |
Group-based Behavioral Intervention
n=61 Participants
The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
|
Health Education Materials Only
n=54 Participants
Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
|
|---|---|---|
|
BMI Z-score(for Gender and Age)at 6-months
|
-0.129 Z-score
Standard Deviation 0.21
|
0.001 Z-score
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: 12-months post-interventionThe body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
Outcome measures
| Measure |
Group-based Behavioral Intervention
n=58 Participants
The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
|
Health Education Materials Only
n=50 Participants
Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
|
|---|---|---|
|
BMI Z-score(for Gender and Age)at 12-months
|
-0.090 Z-score
Standard Deviation 0.29
|
0.001 Z-score
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 6- and 12-months post-interventionOutcome measures
Outcome data not reported
Adverse Events
Group-based Behavioral Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education Materials Only
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place