Overweight and ObesityHMHCNCT03866902
Healthy Mothers-Healthy Children Nutrition
A study testing Nutrition and Physical Activity Intervention and English for Second Language Intervention in people with Overweight and Obesity and Adiposity, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Adiposity, Nutrient; Excess
- What is being tested?
- Nutrition and Physical Activity Intervention and English for Second Language Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- heart murmur
- congenital heart disease
- family history of sudden death
- difficulty exercising
- psychological problems
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Healthy Mothers-Healthy Children: An Intervention With Hispanic Mothers and Their Young 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, and self-efficacy and their 3-5 year old children improve their adiposity and weight gain trajectory and health behaviors.
Read the 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.
- Conditions
- Overweight and Obesity, Adiposity, Nutrient; Excess, Physical Activity
- Being tested
- Nutrition and Physical Activity Intervention, English for Second Language Intervention
- Keywords
- overweight, obesity, adiposity, nutrition, physical activity, Hispanic
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Physical Activity InterventionBehavioural
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.
English for Second Language InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mother's Height From Baseline (Time 1) to Time 2
Height in centimeters
Measured: 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
Measured: Baseline (Time 1), Time 3 (approximately 15 months)
Change in Children's Height From Baseline (Time 1) to Time 2
Height in centimeters
Measured: 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
Measured: Baseline (Time 1), Time 3 (approximately 15 months)
Change in Mother's Weight From Baseline (Time 1) to Time 2
Weight in kilograms
Measured: 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
Measured: Baseline (Time 1), Time 3 (approximately 15 months)
Change in Children's Weight From Baseline (Time 1) to Time 2
Weight in kilograms
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (Time 1), Time 3 (approximately 15 months)
Secondary outcomes (10)
Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start8 Feb 2019
- Primary completion13 Apr 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomized controlled repeated measures study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Hudson Santos, University of Miami
- Investigators
- Hudson Santos, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866902
- Sponsor's protocol ID
- 20220623
- Other IDs
- 1R01NR017199-01, 17-0979
- Acronym
- HMHC
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2019
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32153971
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Mothers-Healthy Children: An Intervention With Hispanic Mothers and Their Young Children
- ClinicalTrials.gov ID
- NCT03866902
- Acronym / sponsor ID
- HMHC / 20220623
- Conditions
- Overweight and Obesity, Adiposity, Nutrient; Excess, Physical Activity
- Keywords
- overweight, obesity, adiposity, nutrition, physical activity, Hispanic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two group randomized controlled repeated measures study
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Physical Activity Intervention | Experimental | Behavioral: Nutrition and Physical Activity InterventionClasses 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. |
| 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. |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- heart murmur
- congenital heart disease
- family history of sudden death
- difficulty exercising
- psychological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and Physical Activity InterventionMothers. 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. | Behavioural | Nutrition and Physical Activity Intervention |
| English for Second Language InterventionMothers. 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. | Other | – |
Primary outcome
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
Change in Mother's Height From Baseline (Time 1) to Time 3
Time frame: Baseline (Time 1), Time 3 (approximately 15 months)
Height in centimeters
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
Change in Children's Height From Baseline (Time 1) to Time 3
Time frame: Baseline (Time 1), Time 3 (approximately 15 months)
Height in centimeters
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
Change in Mother's Weight From Baseline (Time 1) to Time 3
Time frame: Baseline (Time 1), Time 3 (approximately 15 months)
Weight in kilograms
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
Change in Children's Weight From Baseline (Time 1) to Time 3
Time frame: Baseline (Time 1), Time 3 (approximately 15 months)
Weight in kilograms
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
Change in Mother's BMI From Baseline (Time 1) to Time 3
Time frame: 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
Time frame: 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 Children's BMI Percentile From Baseline (Time 1) to Time 3
Time frame: 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 (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
Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3
Time frame: 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
Time frame: 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
Time frame: 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 2
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Triceps skinfolds in Millimeters
Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3
Time frame: 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
Time frame: 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
Time frame: Baseline (Time 1), Time 3 (approximately 15 months)
Triceps skinfolds in millimeters
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
Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3
Time frame: 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
Time frame: 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
Time frame: Baseline (Time 1), Time 3 (approximately 15 months)
Subscapular skinfolds in millimeters
10 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32153971Berry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hudson Santos, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Physical Activity Intervention and English for Second Language Intervention in people with Overweight and Obesity and Adiposity, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mother's Height From Baseline (Time 1) to Time 2 (time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.