Healthy Mothers on the Move

Not Applicable

Completed

• Conditions: Pregnancy; Postpartum Period

• Registration Number: NCT01584063
• Lead Sponsor: University of Michigan

Brief Summary

Healthy Mothers on the Move (Healthy MOMs), was a prospective randomized controlled trial that aimed to demonstrate the effectiveness of a healthy lifestyle intervention to reduce risk factors for obesity and type 2 diabetes. This behavioral intervention was tailored to the needs of pregnant and postpartum Latino women. This study was conducted between 2004 and 2006 in southwest Detroit.

Detailed Description

Specific Aims

1. Intervention group participants will have improved levels of protective behaviors (improved daily dietary composition and increased level of physical activity) that reduce the risk of type 2 diabetes compared to control group.

2. Intervention group participants will have improved their status on clinical measures of risk for type 2 diabetes (anthropometric and metabolic status) compared to the control group.

3. To assess whether theory-based variables, including changes in attitudes, behavioral and control beliefs, perceived social support and behavioral intention change from baseline, and whether these changes influence behavioral outcomes.

4. To identify aspects of project planning and implementation that contributed to achievement of behavioral and clinical outcomes. Measures include recruitment, retention and intervention participation rates, barriers and facilitators of participation; and community involvement in, and satisfaction with, intervention components and project activities; and fidelity of intervention components.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2012-04
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 276

Inclusion Criteria

• 18 years of age or older
• A resident of Southwest Detroit
• Less than 20 weeks gestational at the eligibility screening

Exclusion Criteria

women with:

• Type 1 or type 2 diabetes
• Incompetent cervix/cerclage
• Active thyroid
• Multiple gestation
• Cardiac, vascular or pulmonary disease
• Drug or alcohol addiction
• Serious physical or mental illness or condition that would substantially interfere with participation in or completion of the entire intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical Activity
Diet

Secondary Outcome Measures

Name	Time	Method
Weight (gain during pregnancy, postpartum retention)
Metabolic (e.g., glucose)