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Behavioral Intervention

Home visitation + HABITS program for 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 12 months

Awards & highlights

HABITS Trial 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.

HABITS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My child is between 0 and 4 years old.

HABITS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months

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 (H-IDEA)

Household environment (HFA)

Other outcome measures

Demographic History

Maternal eating practices

Maternal feeding practices

+2 more

HABITS 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,277,881 Total Patients Enrolled

72 Trials studying Obesity

473,982 Patients Enrolled for Obesity

National Institute on Minority Health and Health Disparities (NIMHD)NIH

380 Previous Clinical Trials

1,215,506 Total Patients Enrolled

39 Trials studying Obesity

254,082 Patients Enrolled for Obesity

Sarah J. Salvy, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

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

Are there still openings in this experiment for participants?

"Unfortunately, the information on clinicaltrials.gov states that this specific trial has ceased recruitment of new participants since July 14th 2022. Despite that earlier closure, there are still 1008 other medical studies currently searching for volunteers."

Answered by AI

Is it possible for me to join this medical trial?

"This research is recruiting 596 individuals, aged 0 to 75, struggling with obesity. There are two specific qualifications: 1) Mother-child dyads must enroll together and both parties must meet the criteria; 2) Ages of 18 -75 years old for adults and 0-4 years old for children."

Answered by AI

What is the main objective of this research endeavor?

"The principal aim of this clinical trial, with measurements scheduled at the commencement and 6-month and 12-month intervals, is to monitor weight gain in children. Secondary objectives involve evaluating household food availability through a modified Home Food Assessment (HFA) linked to 5 specific behaviors, assessing maternal feeding practices via an amended frequency measure from NHANES, as well as measuring maternal eating habits using another adjusted frequency measure sourced from NHANES related to target habit behaviours for both activities."

Answered by AI