NCT03866902: HMHC

Healthy Mothers-Healthy Children Nutrition

Completed NA Results posted Last updated 13 August 2024

What this trial tests

NA trial testing Nutrition and Physical Activity Intervention in Overweight and Obesity in 578 participants. Completed in 30 June 2024.

Timeline

8 February 2019

Primary endpoint
13 April 2023

30 June 2024

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	578
Start date	8 February 2019
Primary completion	13 April 2023
Estimated completion	30 June 2024
Sites	1 location across United States

Drugs / interventions tested

• Nutrition and Physical Activity Intervention
• English for Second Language Intervention

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →
• Adiposity — all drugs for Adiposity →
• Nutrient; Excess — all drugs for Nutrient; Excess →
• Physical Activity — all drugs for Physical Activity →

Sponsor

University of Miami

Who can join

Adults 3 to 50, any sex, with Overweight and Obesity or Adiposity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Mother's Height From Baseline (Time 1) to Time 2 Primary · Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Height in centimeters

Group	Value	95% CI
Nutrition and Physical Activity Intervention	-0.00977	± 0.485
English for Second Language Intervention	0.000505	± 0.00503

Change in Mother's Height From Baseline (Time 1) to Time 3 Primary · Baseline (Time 1), Time 3 (approximately 15 months)

Height in centimeters

Group	Value	95% CI
Nutrition and Physical Activity Intervention	-0.00116	± 0.0108
English for Second Language Intervention	0	± 0

Change in Children's Height From Baseline (Time 1) to Time 2 Primary · Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Height in centimeters

Group	Value	95% CI
Nutrition and Physical Activity Intervention	8.62	± 3.38
English for Second Language Intervention	7.86	± 3.20

Change in Children's Height From Baseline (Time 1) to Time 3 Primary · Baseline (Time 1), Time 3 (approximately 15 months)

Height in centimeters

Group	Value	95% CI
Nutrition and Physical Activity Intervention	11.5	± 3.39
English for Second Language Intervention	10.7	± 3.65

Change in Mother's Weight From Baseline (Time 1) to Time 2 Primary · Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Weight in kilograms

Group	Value	95% CI
Nutrition and Physical Activity Intervention	0.0776	± 3.68
English for Second Language Intervention	-0.431	± 4.08

Change in Mother's Weight From Baseline (Time 1) to Time 3 Primary · Baseline (Time 1), Time 3 (approximately 15 months)

Weight in kilograms

Group	Value	95% CI
Nutrition and Physical Activity Intervention	0.488	± 4.25
English for Second Language Intervention	0.435	± 4.24

Change in Children's Weight From Baseline (Time 1) to Time 2 Primary · Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Weight in kilograms

Group	Value	95% CI
Nutrition and Physical Activity Intervention	3.36	± 2.50
English for Second Language Intervention	3.11	± 2.40

Change in Children's Weight From Baseline (Time 1) to Time 3 Primary · Baseline (Time 1), Time 3 (approximately 15 months)

Weight in kilograms

Group	Value	95% CI
Nutrition and Physical Activity Intervention	4.81	± 3.39
English for Second Language Intervention	4.63	± 3.33

Change in Mother's BMI From Baseline (Time 1) to Time 2 Primary · Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Calculation of BMI in Mothers in kilograms divided by meters squared

Group	Value	95% CI
Nutrition and Physical Activity Intervention	0.0437	± 1.62
English for Second Language Intervention	-0.170	± 1.66

Change in Mother's BMI From Baseline (Time 1) to Time 3 Primary · Baseline (Time 1), Time 3 (approximately 15 months)

Calculation of BMI in Mothers in kilograms divided by meters squared

Group	Value	95% CI
Nutrition and Physical Activity Intervention	0.194	± 1.86
English for Second Language Intervention	0.195	± 1.73

Change in Children's BMI Percentile From Baseline (Time 1) to Time 2 Primary · Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

Calculation of BMI measured in percentage in Children. Calculated by the percentage of the mean BMI.

Group	Value	95% CI
Nutrition and Physical Activity Intervention	-7.21	± 18.8
English for Second Language Intervention	-7.69	± 18.9

Change in Children's BMI Percentile From Baseline (Time 1) to Time 3 Primary · Baseline (Time 1), Time 3 (approximately 15 months)

Calculation of BMI Percentile in Children. Calculated by the percentage of the mean BMI.

Group	Value	95% CI
Nutrition and Physical Activity Intervention	-8.69	± 18.8
English for Second Language Intervention	-7.21	± 20.8

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to prevent obesity in children aged 2 to 4 years old.
   Phillips SM, Spiga F, Moore TH, Dawson S, et al · · 2025 · cited 3× · PMID 40494564 · DOI 10.1002/14651858.cd015326.pub2
2. Rationale, design, and methodology for the healthy mothers-healthy children study: a randomized controlled trial.
   Berry DC, Gonzales C, Montano NP, Perreira KM, et al · · 2019 · cited 2× · PMID 32153971 · DOI 10.1186/s40795-019-0322-7