Healthy Mothers-Healthy Children: An Intervention With Hispanic Mothers and Their Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 578
- 试验地点
- 2
- 主要终点
- Change in Children's Weight From Baseline (Time 1) to Time 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •for mothers will be:
- •heart murmur
- •congenital heart disease
- •family history of sudden death
- •difficulty exercising
- •psychological problems
研究组 & 干预措施
Nutrition and Physical Activity Intervention
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.
干预措施: Nutrition and Physical Activity Intervention (Behavioral)
English for Second Language Intervention
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.
干预措施: English for Second Language Intervention (Other)
结局指标
主要结局
Change in Children's Weight From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Weight in kilograms
Change in Children's Weight From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Weight in kilograms
Change in Mother's BMI From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Calculation of BMI in Mothers in kilograms divided by meters squared
Change in Children's BMI Percentile From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Calculation of BMI Percentile in Children. Calculated by the percentage of the mean BMI.
Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Triceps skinfolds in Millimeters
Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Triceps skinfolds in millimeters
Change in Mother's Height From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Height in centimeters
Change in Mother's Height From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Height in centimeters
Change in Children's Height From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Height in centimeters
Change in Children's Height From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Height in centimeters
Change in Mother's Weight From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Weight in kilograms
Change in Mother's Weight From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Weight in kilograms
Change in Mother's BMI From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Calculation of BMI in Mothers in kilograms divided by meters squared
Change in Children's BMI Percentile From Baseline (Time 1) to Time 2
时间窗: 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.
Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Waist Circumference in centimeters
Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Waist Circumference in centimeters
Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Waist circumference in centimeters
Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Waist circumference in Centimeters
Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Triceps skinfolds in millimeters
Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Triceps skinfolds in millimeters
Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Subscapular skinfolds in millimeters
Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Subscapular skinfolds in millimeters
Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2
时间窗: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Subscapular skinfolds in millimeters
Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3
时间窗: Baseline (Time 1), Time 3 (approximately 15 months)
Subscapular skinfolds in millimeters
次要结局
- 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 Children 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 Exercise Self-Efficacy Questionnaire 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 (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 (24 Hour Food Recall) for 3 Days in Children From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months))
- Change in Eating Self-Efficacy Questionnaire 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 Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months))
- Change in Health Behaviors (24 Hour Food Recall) for 3 Days 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 (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 9 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))
- Change in Health Behaviors (Accelerometer Measurement for 7 Days) 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 (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months))
- Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children 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 Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months))
研究者
Hudson Santos
Professor
University of Miami