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Completed

NCT Number: NCT01584063

Healthy Mothers on the Move

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.

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Key information

Conditions

Pregnancy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Postpartum Period

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy MOMs Healthy Lifestyle Intervention

Behavioral

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.

Primary outcomes

  1. Diet

  2. Physical Activity

Secondary outcomes

  1. Weight (gain during pregnancy, postpartum retention)

  2. Metabolic (e.g., glucose)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: Healthy MOMs

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 24, 2012
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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