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Nutrition and Physical Activity Program for Obesity (HMHC Trial)

N/A
Waitlist Available
Led By Diane C Berry, 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

Summary

This trial tests a program of nutrition and exercise education for overweight Hispanic mothers and their young children, followed by several months of regular check-ins. The goal is to help mothers lose weight and improve health habits while preventing excessive weight gain in their children. The study targets Hispanic families to reduce future health risks like diabetes and heart disease.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My BMI is above the 25th percentile for my age and gender.
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My child is between 3 and 5 years old.

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)
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutrition and Physical Activity Intervention
2019
N/A
~580

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lifestyle modification programs for obesity focus on behavioral and educational interventions to promote sustainable weight loss. These programs aim to change dietary habits, increase physical activity, and improve coping skills. Behavioral interventions involve self-monitoring, goal setting, and problem-solving to help patients adhere to their weight loss plans. Educational interventions provide knowledge about nutrition and physical activity, empowering patients to make healthier choices. These approaches are crucial for obesity patients as they address the root causes of weight gain and help in achieving long-term health benefits.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,548 Previous Clinical Trials
4,268,676 Total Patients Enrolled
65 Trials studying Obesity
57,844 Patients Enrolled for Obesity
University of MiamiLead Sponsor
944 Previous Clinical Trials
426,803 Total Patients Enrolled
22 Trials studying Obesity
8,418 Patients Enrolled for Obesity
National Institute of Nursing Research (NINR)NIH
599 Previous Clinical Trials
10,376,456 Total Patients Enrolled
16 Trials studying Obesity
2,792 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
~88 spots leftby Oct 2025