Trial Outcomes & Findings for Community Active and Healthy Families (NCT NCT04414553)
NCT ID: NCT04414553
Last Updated: 2025-04-03
Results Overview
Age- and sex-specific BMI expressed as percent of the 95th percentile. Child Body Mass Index is calculated from child height and weight measurement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
4 months
Results posted on
2025-04-03
Participant Flow
Participating families were recruited via referral from their primary care provider at academic-based general pediatrics clinics (both sites) or community-based recruitment from among participants in programming at a Latino immigrant-serving family resource center and at nearby elementary schools. (Colorado only). Recruitment occurred between Jan-March 2023.
This was a single arm study where all participants who enrolled were assigned to complete the study intervention.
Participant milestones
| Measure |
Community-AHF
Participants in this arm will receive the Community Active and Healthy Families Intervention
Community Active and Healthy Families: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
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|---|---|
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Overall Study
STARTED
|
78
|
|
Overall Study
# of Parents
|
39
|
|
Overall Study
# of Children
|
39
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Community-AHF
Participants in this arm will receive the Community Active and Healthy Families Intervention
Community Active and Healthy Families: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
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|---|---|
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Overall Study
Lost to Follow-up
|
20
|
Baseline Characteristics
The # analyzed per row differs as we are looking at parent and child mean age separately
Baseline characteristics by cohort
| Measure |
Community-AHF
n=78 Participants
Participants in this arm will receive the Community Active and Healthy Families Intervention
Community Active and Healthy Families: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
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|---|---|
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Age, Categorical
<=18 years
|
39 Participants
n=78 Participants
|
|
Age, Categorical
Between 18 and 65 years
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39 Participants
n=78 Participants
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Age, Categorical
>=65 years
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0 Participants
n=78 Participants
|
|
Age, Continuous
Child Age
|
10.1 years
STANDARD_DEVIATION 2.2 • n=39 Participants • The # analyzed per row differs as we are looking at parent and child mean age separately
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|
Age, Continuous
Parent Age
|
39.6 years
STANDARD_DEVIATION 6.2 • n=39 Participants • The # analyzed per row differs as we are looking at parent and child mean age separately
|
|
Sex: Female, Male
Female
|
54 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Latino Ethnicity of any race
|
78 Participants
n=78 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=78 Participants
|
|
Pre-program %BMIp95, mean (SD)
|
125.35 percent
STANDARD_DEVIATION 23.11 • n=39 Participants • This outcome only applies to the child participant
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|
BMI Category
Overweight (BMI 85-94%tile)
|
1 Participants
n=39 Participants • Only children had BMI outcomes measured
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|
BMI Category
Obese (BMI 95-99%tile)
|
2 Participants
n=39 Participants • Only children had BMI outcomes measured
|
|
BMI Category
Severe obesity (BMI >99%tile)
|
36 Participants
n=39 Participants • Only children had BMI outcomes measured
|
|
Child Physical Activity
Low Health Risk (6-7 days/week)
|
5 participants
n=39 Participants • This measure of physical activity in the last week applies to the child only
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|
Child Physical Activity
Medium Health Risk (3-5 days/week)
|
11 participants
n=78 Participants • This measure of physical activity in the last week applies to the child only
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|
Child Physical Activity
High Health Risk (0-1 times/week)
|
23 participants
n=78 Participants • This measure of physical activity in the last week applies to the child only
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|
Child Physical Activity
Medical Contraindication
|
0 participants
n=78 Participants • This measure of physical activity in the last week applies to the child only
|
|
Parent Self Efficacy
|
21.00 units on a scale
STANDARD_DEVIATION 1.87 • n=39 Participants • This measure is only for the parents
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|
Parent Perceived Stress
|
18.10 units on a scale
STANDARD_DEVIATION 20.52 • n=39 Participants • This is a parent only measure
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PRIMARY outcome
Timeframe: 4 monthsPopulation: Children who had both pre/post program data
Age- and sex-specific BMI expressed as percent of the 95th percentile. Child Body Mass Index is calculated from child height and weight measurement.
Outcome measures
| Measure |
Community-AHF
n=29 Participants
Participants in this arm will receive the Community Active and Healthy Families Intervention
Community Active and Healthy Families: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
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|---|---|
|
%BMIp95
|
122.35 percent of the 95th percentile of BMI
Standard Deviation 15.95
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Children with complete pre/post data
This measure examines BMI category of overweight, obesity, severe obesity pre/post program
Outcome measures
| Measure |
Community-AHF
n=29 Participants
Participants in this arm will receive the Community Active and Healthy Families Intervention
Community Active and Healthy Families: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
|
|---|---|
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BMI Category
Overweight (BMI 85-94%tile)
|
0 Participants
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|
BMI Category
Obese (BMI 95-99%tile)
|
3 Participants
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BMI Category
Severe obesity (BMI >99%tile)
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26 Participants
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SECONDARY outcome
Timeframe: 4monthsPopulation: Participants with complete pre/post data
parent-report of the number of days the child is physically active for 60 minutes during a typical week Range 0-7, Higher scores indicate a better outcome (more physical activity)
Outcome measures
| Measure |
Community-AHF
n=29 Participants
Participants in this arm will receive the Community Active and Healthy Families Intervention
Community Active and Healthy Families: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
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|---|---|
|
Child Physical Activity
Low Health Risk (6-7 days/week)
|
13 Participants
|
|
Child Physical Activity
Medium Health Risk (3-5 days/week)
|
5 Participants
|
|
Child Physical Activity
Low Health Risk (0-1 days/week)
|
10 Participants
|
|
Child Physical Activity
Medical Contraindication
|
1 Participants
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SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants with complete pre/post data
4 questions related to self efficacy Range 5-25, Higher scores indicate a better outcome (more parenting self efficacy)
Outcome measures
| Measure |
Community-AHF
n=29 Participants
Participants in this arm will receive the Community Active and Healthy Families Intervention
Community Active and Healthy Families: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
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|---|---|
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Parenting Self-Efficacy
|
20.14 units on a scale
Standard Deviation 1.27
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SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants with complete pre/post data
The 10-item Perceived Stress Score measures global perceived stress experienced across the past 30 days. Range: 0-40, lower scores indicate a better outcome (less stress)
Outcome measures
| Measure |
Community-AHF
n=29 Participants
Participants in this arm will receive the Community Active and Healthy Families Intervention
Community Active and Healthy Families: Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
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|---|---|
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Parent Perceived Stress
|
20.52 units on a scale
Standard Deviation 6.29
|
Adverse Events
Community-AHF
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