- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03866902
Healthy Mothers-Healthy Children Nutrition (HMHC)
Healthy Mothers-Healthy Children: An Intervention With Hispanic Mothers and Their Young Children
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina At Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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. |
Active Comparator: 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mother's Height from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Height in centimeters
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Children's Height from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Height in centimeters
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Mother's Weight from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Weight in kilograms
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Children's Weight from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Weight in kilograms
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Mother's BMI from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Calculation of BMI in Mothers in kilograms divided by meters squared
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Children's BMI Percentile from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
Calculation of BMI Percentile in Children
|
Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
Change in Children's BMI Percentile from Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Calculation of BMI Percentile in Children
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Mother's Adiposity (Waist Circumference) from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Waist Circumference in centimeters
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Children's Adiposity (Waist Circumference) from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Waist circumference in Centimeters
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Mother's Adiposity (Triceps Skinfold) from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Triceps skinfolds in millimeters
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Children's Adiposity (Triceps Skinfold) from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Triceps skinfolds in millimeters
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Subscapular skinfolds in millimeters
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Change in Children's Adiposity (Subscapular Skinfolds) from Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Subscapular skinfolds in millimeters
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
There are 23 questions with a range of answers for each question.
Each question is scored individually as a predetermined healthy or unhealthy choice.
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
There are 23 questions with a range of answers for each question.
Each question is scored individually as a predetermined healthy or unhealthy choice.
|
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
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
There are 34 questions and the answer choices are never, sometime, often or routinely.
Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3.
The 34 questions are summed to provide a total score.
A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors.
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
There are 34 questions and the answer choices are never, sometime, often or routinely.
Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3.
The 34 questions are summed to provide a total score.
A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors.
|
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
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
Phone Interview with the Mother on a Monday, Tuesday and Wednesday.
The research assistant will ask the mother what she ate at breakfast, lunch, dinner and snacks and approximate amounts.
This information will be entered into nutritionistpro a software program.
Then total calories, protein, carbohydrate and fat can be calculated for each day.
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Phone Interview with the Mother on a Monday, Tuesday and Wednesday.
The research assistant will ask the mother what she ate at breakfast, lunch, dinner and snacks and approximate amounts.
This information will be entered into nutritionistpro a software program.
Then total calories, protein, carbohydrate and fat can be calculated for each day.
|
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 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
Phone Interview with the Mother on a Monday, Tuesday and Wednesday.
The research assistant will ask the mother what her child ate at breakfast, lunch, dinner and snacks and approximate amounts.
This information will be entered into nutritionistpro a software program.
Then total calories, protein, carbohydrate and fat can be calculated for each day.
|
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 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Phone Interview with the Mother on a Monday, Tuesday and Wednesday.
The research assistant will ask the mother what her child ate at breakfast, lunch, dinner and snacks and approximate amounts.
This information will be entered into nutritionistpro a software program.
Then total calories, protein, carbohydrate and fat can be calculated for each day.
|
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
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
The Mother will wear an accelerometer for 7 days total.
This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
The Mother will wear an accelerometer for 7 days total.
This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.
|
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
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
The Child will wear an accelerometer for 7 days total.
This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
The Child will wear an accelerometer for 7 days total.
This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.
|
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
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday.
The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating.
The 25 questions are added to produce a total score.
A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.
|
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
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday.
The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating.
The 25 questions are added to produce a total score.
A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.
|
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
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
This is a 18 question questionnaire asking how much difficulty the Mother has with exercise.
The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it.
The numbers are summed for a total score.
A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise.
|
Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
|
Change in Exercise Self-Efficacy Questionnaire in Mothers from Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
This is a 18 question questionnaire asking how much difficulty the Mother has with exercise.
The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it.
The numbers are summed for a total score.
A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise.
|
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hudson Santos, PhD, University of Miami
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220623
- 1R01NR017199-01 (U.S. NIH Grant/Contract)
- 17-0979 (Other Identifier: UNC Chapel Hill)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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