Healthy Mothers on the Move

Pregnancy Clinical Trial

— Healthy MOMs  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584063
• Other study ID #: MOMS-2002
• Status: Completed
• Phase: N/A
• Start date: February 2004
• Est. completion date: November 2006

Study information

• Verified date: April 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postpartum Period
• Pregnancy

Intervention

Behavioral:
• Healthy MOMs Healthy Lifestyle Intervention
These women received the culturally tailored Healthy MOMs Healthy Lifestyle Intervention, which included social support from Women's Health Advocates (community health workers) and peers, and the Healthy MOMs curriculum. This intervention curriculum covered topics related to healthy eating, physical activity, and stress management during pregnancy and postpartum. General information about pregnancy and the postpartum period were also provided. This intervention was delivered during 10 group meetings and 4 home visits.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet
Primary	Physical Activity
Secondary	Weight (gain during pregnancy, postpartum retention)
Secondary	Metabolic (e.g., glucose)