Trial Outcomes & Findings for Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities (NCT NCT04731506)

Results Overview

We used the mixed-effect regression model for the BMI z-score, weight, and BMI, regardless adults or kids. Weight was measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. For a child's BMI z-score, we use the formula Z=((BMI/M)\^{L}-1)/(L\\times S), where M, L, and S are parameters specific to the child's sex and age. For specific age and sex combinations, the parameters M, L, and S are obtained from reference data tables, provided by the CDC (https://www.cdc.gov/growthcharts/extended-bmi-data-files.htm). A Z-score indicates how many standard deviations a data point is from the mean. For children and adolescents, specific z-score ranges are used to define weight status: (Negative Z-score, below mean) underweight (\<-2), healthy weight (-2 to +1), (Positive Z-score, above mean) overweight (+1 to +2), and obese (\>+2). Z-scores \& Health: ≥0 greater risk for developing cardiovascular disease. \<-2 osteoporosis and bone fractures risk.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

12 months

Results posted on

2026-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Child- Waitlist Children directly participated in data collection at baseline and 12 months. Children did not participate in the intervention activities led by the research team. Their parents (parent- wait-list) were wait-listed and received an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time. Then they were placed on a 6-month wait-list (delayed start) in the FC program.	Parent- Standard Care Parent participants will receive an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time, two in-person support sessions spaced, and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 12 months.	Parent- Waitlist Parent participants who are wait-listed will receive an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time, and then will be placed on a 6-month delayed start (wait-list) in the FC program.	Child- Standard Care Children directly participated in data collection at baseline and 12 months. Children did not participate in the intervention activities led by the research team. Their parents (parent- standard care) received an activity workbook that promotes increased physical activity, healthy diets and decreased screen time, two in-person support sessions, and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 12 months.
Overall Study STARTED	12	25	13	26
Overall Study COMPLETED	10	8	11	8
Overall Study NOT COMPLETED	2	17	2	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parent- Standard Care n=25 Participants Parent participants will receive an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time, two in-person support sessions spaced, and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 12 months.	Child- Standard Care n=26 Participants Children directly participated in data collection at baseline and 12 months. Children did not participate in the intervention activities led by the research team. Their parents (parent- standard care) received an activity workbook that promotes increased physical activity, healthy diets and decreased screen time, two in-person support sessions, and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 12 months.	Parent- Waitlist n=13 Participants Parent participants who are wait-listed will receive an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time, and then will be placed on a 6-month delayed start (wait-list) in the FC program.	Child- Waitlist n=12 Participants Children directly participated in data collection at baseline and 12 months. Children did not participate in the intervention activities led by the research team. Their parents (parent- wait-list) were wait-listed and received an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time. Then they were placed on a 6-month wait-list (delayed start) in the FC program.	Total n=76 Participants Total of all reporting groups
Age, Continuous	39.4 years STANDARD_DEVIATION 1.6 • n=25 Participants	9.8 years STANDARD_DEVIATION 2.2 • n=26 Participants	37.2 years STANDARD_DEVIATION 9.5 • n=13 Participants	9.8 years STANDARD_DEVIATION 8.2 • n=12 Participants	24.05 years STANDARD_DEVIATION 2.6 • n=76 Participants
Sex: Female, Male Female	14 Participants n=25 Participants	24 Participants n=26 Participants	13 Participants n=13 Participants	7 Participants n=12 Participants	58 Participants n=76 Participants
Sex: Female, Male Male	11 Participants n=25 Participants	2 Participants n=26 Participants	0 Participants n=13 Participants	5 Participants n=12 Participants	18 Participants n=76 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Z-score	—	2.1 z-score STANDARD_DEVIATION 0.4 • n=26 Participants • Z-score for children only	—	1.7 z-score STANDARD_DEVIATION 0.8 • n=12 Participants • Z-score for children only	2.0 z-score STANDARD_DEVIATION 0.6 • n=38 Participants • Z-score for children only
BMI	32.2 Kg/m^2 STANDARD_DEVIATION 6.3 • n=25 Participants • BMI for adults	—	37.7 Kg/m^2 STANDARD_DEVIATION 13.9 • n=13 Participants • BMI for adults	—	34.1 Kg/m^2 STANDARD_DEVIATION 9.8 • n=38 Participants • BMI for adults

PRIMARY outcome

Timeframe: 12 months

We used the mixed-effect regression model for the BMI z-score, weight, and BMI, regardless adults or kids. Weight was measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. For a child's BMI z-score, we use the formula Z=((BMI/M)\^{L}-1)/(L\\times S), where M, L, and S are parameters specific to the child's sex and age. For specific age and sex combinations, the parameters M, L, and S are obtained from reference data tables, provided by the CDC (https://www.cdc.gov/growthcharts/extended-bmi-data-files.htm). A Z-score indicates how many standard deviations a data point is from the mean. For children and adolescents, specific z-score ranges are used to define weight status: (Negative Z-score, below mean) underweight (\<-2), healthy weight (-2 to +1), (Positive Z-score, above mean) overweight (+1 to +2), and obese (\>+2). Z-scores \& Health: ≥0 greater risk for developing cardiovascular disease. \<-2 osteoporosis and bone fractures risk.

Outcome measures

Outcome measures
Measure	Child- Standard Care n=8 Participants Children directly participated in data collection at baseline and 12 months. Children did not participate in the intervention activities led by the research team. Their parents (parent- standard care) received an activity workbook that promotes increased physical activity, healthy diets and decreased screen time, two in-person support sessions, and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 12 months.	Child- Waitlist n=10 Participants Children directly participated in data collection at baseline and 12 months. Children did not participate in the intervention activities led by the research team. Their parents (parent- waitlist) were waitlisted and received an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time. Then they were placed on a 6-month waitlist (delayed start) in the FC program.
Child- Change in BMI Z-score at 12 Months From Baseline	-0.158 BMI z score (children) Standard Deviation 0.133	-0.031 BMI z score (children) Standard Deviation 0.276

PRIMARY outcome

Timeframe: 12 months

Adult participant's Body Mass Index (BMI), a standardized way to measure an adult's weight in relation to their height, will be determined at the initial in-person visit, then again at 12 months. Height will be measured in stocking feet with a calibrated stadiometer with a fixed vertical backboard and adjustable headboard. Weight will be measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. BMI will be calculated in kg/m2 using the established Centers for Disease Control and Prevention protocol. Higher scores mean a worse outcome. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.

Outcome measures

Outcome measures
Measure	Child- Standard Care n=8 Participants Children directly participated in data collection at baseline and 12 months. Children did not participate in the intervention activities led by the research team. Their parents (parent- standard care) received an activity workbook that promotes increased physical activity, healthy diets and decreased screen time, two in-person support sessions, and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 12 months.	Child- Waitlist n=11 Participants Children directly participated in data collection at baseline and 12 months. Children did not participate in the intervention activities led by the research team. Their parents (parent- waitlist) were waitlisted and received an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time. Then they were placed on a 6-month waitlist (delayed start) in the FC program.
Adult- Change in BMI at 12 Months From Baseline	-0.700 BMI = kg/m² Standard Deviation 3.14	-4.35 BMI = kg/m² Standard Deviation 12.49

Adverse Events

Parent/Child Dyad- Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent/Child- Waitlist

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

Tzeyu Michaud

University of Nebraska Medical Center

Phone: 4028369195

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place