← Back to Search

Nutrition and Physical Activity Program for Obesity (HMHC Trial)

N/A

Waitlist Available

Led By Hudson Santos, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

age 18 years or older

a BMI > 25th percentile for age and gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 15 months)

Awards & highlights

HMHC Trial Summary

This trial will study whether a 12-week intervention program can help improve weight, health behaviors, and self-efficacy in Hispanic women and their young children.

Who is the study for?

This trial is for overweight or obese Hispanic mothers who understand Spanish, are 18 years or older with a BMI over 25, and their children aged 3-5 with a BMI above the 25th percentile. Participants should have limited English skills and low acculturation scores. Both mother and child must live together and consent to join the study.Check my eligibility

What is being tested?

The study tests a 12-week program combining nutrition education, exercise guidance, coping skills training, followed by six months of support. It aims to improve body fat levels, weight management, health habits, and self-confidence in both mothers and young children.See study design

What are the potential side effects?

While not explicitly stated for this educational intervention trial on nutrition and physical activity, potential side effects may include muscle soreness from new exercises or dietary changes such as gastrointestinal discomfort.

HMHC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My BMI is above the 25th percentile for my age and gender.

Select...

My child is between 3 and 5 years old.

HMHC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 15 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 15 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 15 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+21 more

Secondary outcome measures

Change in Eating Self-Efficacy Questionnaire in Mothers from Baseline (Time 1) to Time 2

Change in Eating Self-Efficacy Questionnaire in Mothers from Baseline (Time 1) to Time 3

Change in Exercise Self-Efficacy Questionnaire in Mothers from Baseline (Time 1) to Time 2

+13 more

HMHC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nutrition and Physical Activity InterventionExperimental Treatment1 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.

Group II: English for Second Language InterventionActive Control1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,074 Total Patients Enrolled

64 Trials studying Obesity

57,466 Patients Enrolled for Obesity

University of MiamiLead Sponsor

898 Previous Clinical Trials

409,063 Total Patients Enrolled

21 Trials studying Obesity

8,320 Patients Enrolled for Obesity

National Institute of Nursing Research (NINR)NIH

579 Previous Clinical Trials

10,375,794 Total Patients Enrolled

16 Trials studying Obesity

2,874 Patients Enrolled for Obesity

Media Library

Nutrition and Physical Activity Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03866902 — N/A

Obesity Research Study Groups: Nutrition and Physical Activity Intervention, English for Second Language Intervention

Obesity Clinical Trial 2023: Nutrition and Physical Activity Intervention Highlights & Side Effects. Trial Name: NCT03866902 — N/A

Nutrition and Physical Activity Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03866902 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for recruitment into this experiment currently?

"According to clinicaltrials.gov, the doors of this medical study are closed and it is not actively seeking out participants anymore. This trial was initially published on February 8th 2019 with its last update being made on September 28th 2022. However, there remain 1,235 other trials that continue to search for test subjects presently."

Answered by AI

What overarching purpose is this experiment attempting to achieve?

"The primary objective of this research is to measure the Change in Children's Adiposity (Subscapular Skinfolds) from Baseline (Time 1) to Time 3, approximately 15 months later. Secondary goals include evaluating the mothers' Exercise Self-Efficacy Questionnaire and Health Behaviors (24 Hour Food Recall & Health Promoting Lifestyle Profile II). The former comprises 18 queries gauging how confident a mother is with exercise, its scores ranging from 1 representing absolute incapacity up to 10 for total certainty. For quantifying health behaviors, 34 questions are posed about routine activities which receives numerical rating between 0 and 3"

Answered by AI

Is the age criteria for participation in this trial limited to individuals over 50?

"The study population for this medical trial is aged 3 to 50 years old. There are 249 studies which focus on people younger than 18, whereas 769 explore the effects of treatment in patients older than 65."

Answered by AI

Are there any eligibility restrictions for participating in this medical experiment?

"This medical research is recruiting 588 individuals aged 3-50 with a Body Mass Index of over 25kg/m^2. To be eligible, applicants must meet the following prerequisites: 18+ years old and self-identifying as Hispanic, limited English fluency coupled with low acculturation (Short Acculturation Scale for Hispanics score 1.00 to 2.99), ability to comprehend Spanish speech, being in residence with their child and consenting them into the trial alongside themselves; additionally those between ages 3-5 need a BMI higher than age & gender's25th percentile."

Answered by AI