Clinical trial NCT03866902: Healthy Mothers-Healthy Children Nutrition
Official title: Healthy Mothers-Healthy Children: An Intervention With Hispanic Mothers and Their Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Adiposity
Nutrient; Excess
Physical Activity
Keywords: overweight
obesity
adiposity
nutrition
physical activity
Hispanic
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-03-07
Enrollment: 578
Sex: ALL
Minimum age (years): 3
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized controlled repeated measures study
Primary purpose: TREATMENT

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.

Detailed description: Hispanic women and children who become overweight or obese are at risk for developing prediabetes, type 2 diabetes, and cardiovascular disease later in life. To date, there have been no interdisciplinary interventions that have targeted Hispanic women and their 3-5 year old children to improve nutrition and physical activity behaviors to manage adiposity and weight in mothers and prevent excessive adiposity and weight gain trajectory in their children. 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 (nutrition and physical activity), and self-efficacy and their 3-5 year old children improve their adiposity and weight gain trajectory and health behaviors (nutrition and physical activity). The investigators will partner with two federally qualified health departments in Durham and Chatham, North Carolina to enroll Hispanic women and their 3-5 year old children and the investigators will partner with community centers to deliver the intervention. A total of 294 Hispanic women with a BMI \>25 kg/m² and 294 Hispanic 3-5 year old children with a BMI percentile \> 25 will be enrolled over 4 years and randomized to the experimental or equal attention control group. Data will be collected at Time 1 (0 months \[baseline\]) to Time 2 (9 months \[completion of the intervention\]) and Time 1 to Time 3 (15 months \[after 6 months with no contact from the study staff\]). Data collected will include adiposity (primary outcomes: waist circumference, triceps and subscapular skinfolds) in mothers and children and weight (primary outcomes: body mass index \[BMI\] in mothers and BMI percentile in the children). Secondary outcomes will include health behaviors and self-efficacy in the mothers (Adult Health Behavior Questionnaire, Lifestyle Health Promoting Profile II, 3 day 24-Hour Food Recall, and 7 day Accelerometer, Eating Self-Efficacy Scale and Exercise Self-Efficacy Scale) and in the children (7 day Accelerometer and 3 day 24-Hour Food Recall). The investigators will also evaluate the cost of delivering the program for public health departments. Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight and obesity in Hispanic women and slowing adiposity and weight gain trajectory in young Hispanic children is urgently needed to decrease morbidity, mortality, and future health care costs. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Hispanic mothers and children in other communities to assist mothers in managing their weight and preventing excessive adiposity and weight gain in their children. This approach is translatable, real-world, and could be replicated in other areas of the United States.

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

Primary outcomes:
measure: Change in Mother's Height From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Mother's Height From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Children's Height From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Children's Height From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Mother's Weight From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Mother's Weight From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Children's Weight From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Children's Weight From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Mother's BMI From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Mother's BMI From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Children's BMI Percentile From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Children's BMI Percentile From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
measure: Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (approximately 15 months)
Secondary outcomes:
measure: Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
measure: Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
measure: Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
measure: Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
measure: Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
measure: Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
measure: Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
measure: Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
measure: Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of Miami
name: Hudson Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.