Healthy Mothers on the Move

NCT ID: NCT01584063

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-11-30

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.

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.

Conditions

Pregnancy; Postpartum Period

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Healthy MOMs Healthy Lifestyle Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Shah MK, Kieffer EC, Choi H, Schumann C, Heisler M. Mediators and Moderators of the Effectiveness of a Community Health Worker Intervention That Improved Dietary Outcomes in Pregnant Latino Women. Health Educ Behav. 2015 Oct;42(5):593-603. doi: 10.1177/1090198114568307. Epub 2015 Jan 30.

Reference Type: DERIVED

PMID: 25636316 (View on PubMed)

Kieffer EC, Welmerink DB, Sinco BR, Welch KB, Rees Clayton EM, Schumann CY, Uhley VE. Dietary outcomes in a Spanish-language randomized controlled diabetes prevention trial with pregnant Latinas. Am J Public Health. 2014 Mar;104(3):526-33. doi: 10.2105/AJPH.2012.301122. Epub 2013 Jun 13.

Reference Type: DERIVED

PMID: 23763411 (View on PubMed)

Other Identifiers

MOMS-2002

Identifier Type: -

Identifier Source: org_study_id