Healthy Mothers on the Move (Healthy MOMs)

University of Michigan

Status: Completed

Conditions: Postpartum Period; Pregnancy

Treatments: Behavioral: Healthy MOMs Healthy Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01584063

MOMS-2002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 276 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 2 patient groups

Control

No Intervention group

Description:

These women received general information about pregnancy and the postpartum period and tips for stress management. This information was delivered during 3 group meetings during pregnancy and 1 group meeting postpartum by trained staff from a local community mental health agency.

MOMs Healthy Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy MOMs Healthy Lifestyle Intervention