Healthy MOMs: Healthy Mothers on the Move

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT01584063

Collaborator

(none)

276

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Postpartum Period	Behavioral: Healthy MOMs Healthy Lifestyle Intervention	N/A

Detailed Description

Specific Aims

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.
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.
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.
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 Design

Study Type:

Interventional

Actual Enrollment :

276 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 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.
Experimental: 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.	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.

Arm

Intervention/Treatment

No Intervention: Control

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.

Experimental: 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.

Behavioral: Healthy MOMs Healthy Lifestyle Intervention

Outcome Measures

Primary Outcome Measures

Diet []
Physical Activity []

Secondary Outcome Measures

Weight (gain during pregnancy, postpartum retention) []
Metabolic (e.g., glucose) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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