Clinical trial NCT01584063: Healthy Mothers on the Move
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Postpartum Period
Keywords: Mexican Americans
Pregnancy
Diabetes Mellitus Type 2
Prevention
Community health workers
Community based participatory research
Behavioral Intervention
Lifestyle Intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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: 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

Primary outcomes:
measure: Diet
measure: Physical Activity
Secondary outcomes:
measure: Weight (gain during pregnancy, postpartum retention)
measure: Metabolic (e.g., glucose)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.