NCT01584063

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable pregnancy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
Last Updated

July 27, 2023

Status Verified

April 1, 2012

Enrollment Period

2.8 years

First QC Date

April 20, 2012

Last Update Submit

July 25, 2023

Conditions

PregnancyPostpartum Period

Keywords

Mexican AmericansPregnancyDiabetes Mellitus Type 2PreventionCommunity health workersCommunity based participatory researchBehavioral InterventionLifestyle Intervention

Outcome Measures

Primary Outcomes (2)

  • Diet

  • Physical Activity

Secondary Outcomes (2)

  • Weight (gain during pregnancy, postpartum retention)

  • Metabolic (e.g., glucose)

Study Arms (2)

Control

NO INTERVENTION

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.

MOMs Healthy Lifestyle Intervention

EXPERIMENTAL

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

Interventions

Healthy MOMs Healthy Lifestyle InterventionBEHAVIORAL

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.

MOMs Healthy Lifestyle Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • A resident of Southwest Detroit
  • Less than 20 weeks gestational at the eligibility screening

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25636316DERIVED

  • 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.

    PMID: 23763411DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 24, 2012

Study Start

February 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

July 27, 2023

Record last verified: 2012-04