CompletedNot Applicable

Healthy Mothers-Healthy Children Nutrition

United States578 participantsStarted 2019-02-08

Plain-language summary

Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and exercise education, physical activity, coping skills training, and home-based physical activity intervention in Hispanic women and their 3-5 year old children and 6 months of continued monthly contact to help overweight and obese Hispanic mothers improve adiposity, weight, health behaviors, and self-efficacy and their 3-5 year old children improve their adiposity and weight gain trajectory and health behaviors.

Who can participate

Age range3 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria for mothers will be: * age 18 years or older * self-identification as Hispanic * limited English proficiency; little acculturation, as measured by the Short Acculturation Scale for Hispanics with a score from 1.00 to 2.99 * ability to understand spoken Spanish * a BMI \>25kg/m\^2 * residence with the child * consent to join the study and consent for their child to join the study. Inclusion criteria for children will be: * age 3-5 years * ability to understand spoken Spanish * a BMI \> 25th percentile for age and gender Exclusion criteria for mothers will be: * heart murmur * congenital heart disease * family history of sudden death * difficulty exercising * psychological problems

What they're measuring

Change in Mother's Height From Baseline (Time 1) to Time 2

Timeframe: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Change in Mother's Height From Baseline (Time 1) to Time 3

Timeframe: Baseline (Time 1), Time 3 (approximately 15 months)

Change in Children's Height From Baseline (Time 1) to Time 2

Timeframe: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Change in Children's Height From Baseline (Time 1) to Time 3

Timeframe: Baseline (Time 1), Time 3 (approximately 15 months)

Change in Mother's Weight From Baseline (Time 1) to Time 2

Timeframe: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Change in Mother's Weight From Baseline (Time 1) to Time 3

Timeframe: Baseline (Time 1), Time 3 (approximately 15 months)

Change in Children's Weight From Baseline (Time 1) to Time 2

Timeframe: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Trial details

NCT IDNCT03866902

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-13

Results submitted2024-04-11

View on ClinicalTrials.gov More Overweight and Obesity trials

Plain-language summary

Who can participate

Age range3 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Mother's Height From Baseline (Time 1) to Time 2

Timeframe: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Change in Mother's Height From Baseline (Time 1) to Time 3

Timeframe: Baseline (Time 1), Time 3 (approximately 15 months)

Change in Children's Height From Baseline (Time 1) to Time 2

Timeframe: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Change in Children's Height From Baseline (Time 1) to Time 3

Timeframe: Baseline (Time 1), Time 3 (approximately 15 months)

Change in Mother's Weight From Baseline (Time 1) to Time 2

Timeframe: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Change in Mother's Weight From Baseline (Time 1) to Time 3

Timeframe: Baseline (Time 1), Time 3 (approximately 15 months)

Change in Children's Weight From Baseline (Time 1) to Time 2

Timeframe: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)