N/A N=574 Randomized Quadruple-blind Treatment

Healthy Mothers-Healthy Children Nutrition

Overweight and Obesity · Adiposity · Nutrient; Excess · Physical Activity

Bottom Line

View on ClinicalTrials.gov: NCT03866902 ↗

Enrolled (actual)

574

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Change in Mother's Height From Baseline (Time 1) to Time 2 — -0.00977; 0.000505 Centimeters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nutrition and Physical Activity Intervention (Behavioral); English for Second Language Intervention (Other)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mother's Height From Baseline (Time 1) to Time 2	-0.00977; 0.000505	—
PRIMARY Change in Mother's Height From Baseline (Time 1) to Time 3	-0.00116; 0	—
PRIMARY Change in Children's Height From Baseline (Time 1) to Time 2	8.62; 7.86	—
PRIMARY Change in Children's Height From Baseline (Time 1) to Time 3	11.5; 10.7	—
PRIMARY Change in Mother's Weight From Baseline (Time 1) to Time 2	0.0776; -0.431	—
PRIMARY Change in Mother's Weight From Baseline (Time 1) to Time 3	0.488; 0.435	—
PRIMARY Change in Children's Weight From Baseline (Time 1) to Time 2	3.36; 3.11	—
PRIMARY Change in Children's Weight From Baseline (Time 1) to Time 3	4.81; 4.63	—
PRIMARY Change in Mother's BMI From Baseline (Time 1) to Time 2	0.0437; -0.170	—
PRIMARY Change in Mother's BMI From Baseline (Time 1) to Time 3	0.194; 0.195	—
PRIMARY Change in Children's BMI Percentile From Baseline (Time 1) to Time 2	-7.21; -7.69	—
PRIMARY Change in Children's BMI Percentile From Baseline (Time 1) to Time 3	-8.69; -7.21	—
PRIMARY Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2	0.172; 0.661	—
PRIMARY Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3	0.769; 0.399	—
PRIMARY Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2	4.38; 4.77	—
PRIMARY Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3	5.00; 5.71	—
PRIMARY Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2	-0.421; -0.848	—
PRIMARY Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3	-1.77; -0.854	—
PRIMARY Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2	0.734; 0.920	—
PRIMARY Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3	1.02; 1.35	—
PRIMARY Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2	0.697; 0.558	—
PRIMARY Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3	1.00; 0.737	—
PRIMARY Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2	1.13; 0.984	—
PRIMARY Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3	1.06; 1.36	—
SECONDARY Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2	-7; -6.03	—
SECONDARY Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers From Baseline (Time 1) to Time 3	-6.13; -6.67	—
SECONDARY Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 2	-241; 246	—
SECONDARY Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 3	-238; 620	—
SECONDARY Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 2	-27.3; 709	—
SECONDARY Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 3	-695; 276	—
SECONDARY Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2	6.90; 7.08	—
SECONDARY Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3	5.10; 5.70	—
SECONDARY Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2	1.20; 0.797	—
SECONDARY Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3	0.407; 0.995	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03866902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.