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Healthy Mothers on the Move (Healthy MOMs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edith C. Kieffer, University of Michigan
ClinicalTrials.gov Identifier:
NCT01584063
First received: April 20, 2012
Last updated: April 23, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Pregnancy
Postpartum Period
 Behavioral: Healthy MOMs Healthy Lifestyle Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Diet
  • Physical Activity

Secondary Outcome Measures:
  • Weight (gain during pregnancy, postpartum retention)
  • Metabolic (e.g., glucose)

Enrollment: 276
Study Start Date: February 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Edith C. Kieffer, Associate Professor of Social Work, University of Michigan
ClinicalTrials.gov Identifier: NCT01584063     History of Changes
Other Study ID Numbers: MOMS-2002
Study First Received: April 20, 2012
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Mexican Americans
Pregnancy
Diabetes Mellitus Type 2
Prevention
 Community health workers
Community based participatory research
Behavioral Intervention
Lifestyle Intervention

ClinicalTrials.gov processed this record on May 19, 2013