A Pilot Study of Diabetes Risk Reduction Program With WIC Mothers(The Special Supplemental Nutrition Program for Women, Infants, and Children) Overweight WIC Mothers

A Pilot Study of Diabetes Risk Reduction Program With Overweight WIC Mothers

1) to evaluate treatment fidelity of DRRP: study design, training of interventionists, delivery and receipt of the intervention, and application of the intervention in real-life settings; 2) to identify successful strategies for participant recruitment and maintaining active participation; 3) to collect and analyze preliminary indicators of DRRP's effect on dietary intake, physical activity, stress responses, and body weight; and 4) To evaluate sample representativeness of the target audience, implementation and acceptability of DRRP, and attrition rate.

Study Overview

• Status: Completed
• Conditions: Prevention of Weight Gain
• Intervention / Treatment: Other: lifestyle intervention

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan Stat University College of Nursing
    • East Lansing, Michigan, United States, 48824
      • Michigan State University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:Non-pregnant women between 18 and 34 years old who understood and spoke English and had a measured BMI between 25.0 and 39.9 kg/m2 were eligible for this study. Additional inclusion criteria included having a youngest child between 6 weeks and 3.5 years of age enrolled in one of our three collaborating WIC locations, not planning to become pregnant or change WIC clinics during the study, providing accurate contact information, agreeing to notify researchers with changes in contact information or pregnancy status, willingness to accept randomized participation assignments, being willing to participate in the project for 1.5 years, and consenting to have blood glucose tested via finger stick.

Exclusion Criteria: women with fasting blood glucose greater than 126 mg/dl or random blood glucose greater than 200 mg/dl, self-reported type 1 or 2 diabetes or an eating disorder, or inability to walk more than one block without resting or shortness of breath were excluded. Eligible participants provided their individual telephone and address and a telephone number of one back-up contact (relative, friend, or neighbor).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lifestyle intervention; Control group: usual WIC care	Other: lifestyle intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
body weight

Secondary Outcome Measures

Outcome Measure
dietary fat intake, fruit and vegetable intake, physical activity, stress, affects

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

General Publications

• Chang MW, Brown R, Nitzke S. Participant recruitment and retention in a pilot program to prevent weight gain in low-income overweight and obese mothers. BMC Public Health. 2009 Nov 21;9:424. doi: 10.1186/1471-2458-9-424.

Study record dates

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 20, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Estimate): January 15, 2010
• Last Update Submitted That Met QC Criteria: January 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Overweight; Weight Gain
• Other Study ID Numbers: DK74511 (completed); 1R34DK074511-01A1 (U.S. NIH Grant/Contract)