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

Prevention of Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944060
• Other study ID #: DK74511 (completed)
• Secondary ID: 1R34DK074511-01A
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2009
• Last updated: January 14, 2010

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: NIDDKUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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 Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prevention of Weight Gain
• Weight Gain

Intervention

Other:
• lifestyle intervention

Locations

Country	Name	City	State
United States	Michigan Stat University College of Nursing	East Lansing	Michigan
United States	Michigan State University College of Nursing	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight
Secondary	dietary fat intake, fruit and vegetable intake, physical activity, stress, affects