Healthy Mothers-Healthy Children Nutrition

NCT03866902 | Completed Results DMC

• 3 other identifiers: 202206231R01NR017199-0117-0979
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

overweight; obesity; adiposity; nutrition; physical activity; Hispanic

Outcome Measures

Primary Outcomes (24)

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

  Height in centimeters

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

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

  Height in centimeters

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

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

  Height in centimeters

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

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

  Height in centimeters

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

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

  Weight in kilograms

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

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

  Weight in kilograms

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

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

  Weight in kilograms

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

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

  Weight in kilograms

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

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

  Calculation of BMI in Mothers in kilograms divided by meters squared

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

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

  Calculation of BMI in Mothers in kilograms divided by meters squared

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

• Change in Children's BMI Percentile From Baseline (Time 1) to Time 2

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

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

• Change in Children's BMI Percentile From Baseline (Time 1) to Time 3

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

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

• Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2

  Waist Circumference in centimeters

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

• Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3

  Waist Circumference in centimeters

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

• Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2

  Waist circumference in centimeters

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

• Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3

  Waist circumference in Centimeters

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

• Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2

  Triceps skinfolds in Millimeters

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

• Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3

  Triceps skinfolds in millimeters

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

• Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2

  Triceps skinfolds in millimeters

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

• Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3

  Triceps skinfolds in millimeters

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

• Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2

  Subscapular skinfolds in millimeters

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

• Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3

  Subscapular skinfolds in millimeters

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

• Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2

  Subscapular skinfolds in millimeters

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

• Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3

  Subscapular skinfolds in millimeters

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

Secondary Outcomes (16)

• Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 2

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

• Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 3

  Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)

• Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2

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

• Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers From Baseline (Time 1) to Time 3

  Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)

• Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers From Baseline (Time 1) to Time 2

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

Study Arms (2)

Nutrition and Physical Activity Intervention

EXPERIMENTAL

Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months. Classes for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.

Behavioral: Nutrition and Physical Activity Intervention

English for Second Language Intervention

ACTIVE COMPARATOR

Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months. Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.

Other: English for Second Language Intervention

Interventions

Nutrition and Physical Activity Intervention BEHAVIORAL

Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class. Children. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.

Nutrition and Physical Activity Intervention

English for Second Language Intervention OTHER

Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material. Children. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.

English for Second Language Intervention

Eligibility Criteria

• Age: 3 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• age 3-5 years
• ability to understand spoken Spanish
• a BMI \> 25th percentile for age and gender

You may not qualify if:

• heart murmur
• congenital heart disease
• family history of sudden death
• difficulty exercising
• psychological problems

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Berry DC, Gonzales C, Montano NP, Perreira KM, Ammerman AS, Crandell J, Evenson KR, Faith MS, Waters H, Linares C, Comicronrtes YI, Perrin EM. Rationale, design, and methodology for the healthy mothers-healthy children study: a randomized controlled trial. BMC Nutr. 2019 Dec 16;5:58. doi: 10.1186/s40795-019-0322-7. eCollection 2019.

  PMID: 32153971 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Results Point of Contact

• Title: Hudson Santos
• Organization: University of Miami

hsantos@miami.edu

3052845812

Study Officials

• Hudson Santos, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician has created a randomization table in RedCap. After enrollment and baseline assessment, dyads will be randomized to either the intervention or control group using a computer-generated randomization table, stratifying by BMI group, overweight (25 - 29.9 kg/m²) and obese (\>30 kg/m²), and utilizing blocking to help ensure balance between the groups. Mothers will be informed of their group assignment by telephone.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two group randomized controlled repeated measures study

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: March 7, 2019
• Study Start: February 8, 2019
• Primary Completion: April 13, 2023
• Study Completion: June 30, 2024
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)