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Behavioral Intervention

Healthy Habits Program for Childhood Obesity (HABITS Trial)

N/A
Waitlist Available
Led By Sarah J. Salvy, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child must be 0-4 years of age at time of enrollment
Must not have
Mother or primary caregiver currently enrolled in a diet and weight loss program with significant weight loss of 10+ pounds in the last 6 months or unwilling to discontinue from current program
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months
Awards & highlights

Summary

This trial will test whether teaching low-income mothers and children healthy habits reduces obesity risk.

Who is the study for?
This trial is for low-income mothers and their children aged 0-4 who are enrolled in the First Teacher Home Visiting Program. Both mother (or primary caregiver) and child must join together, be generally healthy, and not currently involved in any other weight loss programs. Mothers should not have had significant weight loss recently or have a history of eating disorders.Check my eligibility
What is being tested?
The study is testing if adding a 'Healthy Habits' program to standard home visitation services can prevent obesity in both mothers and young children from low-income families. Participants will either receive this enhanced program or just the standard service to see which is more effective at managing weight.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medications, there are no direct side effects like you'd expect with drugs. However, participants may experience changes in daily routines that could affect their habits and family dynamics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 0 and 4 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My mother or primary caregiver has lost 10+ pounds in the last 6 months due to a diet program.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 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
Weight of Children
Weight of Mothers
Secondary outcome measures
Habit Strength of Targeted Behaviors
Household Environment Assessing the Number of Different Activity-promoting Items Available
Household Environment Assessing the Number of Different Food Items Available
Other outcome measures
Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)
Maternal Eating Practices
Maternal Feeding Practices
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Home visitation + HABITS ProgramExperimental Treatment2 Interventions
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Group II: Standard home visitation programActive Control1 Intervention
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,624 Total Patients Enrolled
72 Trials studying Obesity
473,982 Patients Enrolled for Obesity
National Institute on Minority Health and Health Disparities (NIMHD)NIH
395 Previous Clinical Trials
1,342,584 Total Patients Enrolled
40 Trials studying Obesity
254,458 Patients Enrolled for Obesity
Sarah J. Salvy, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
~53 spots leftby Jul 2025