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

Primary Purpose

Prevention of Weight Gain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lifestyle intervention
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Weight Gain

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Michigan Stat University College of Nursing
  • Michigan State University College of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lifestyle intervention

Arm Description

Control group: usual WIC care

Outcomes

Primary Outcome Measures

body weight

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2009
Last Updated
January 14, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00944060
Brief Title
A Pilot Study of Diabetes Risk Reduction Program With WIC Mothers(The Special Supplemental Nutrition Program for Women, Infants, and Children) Overweight WIC Mothers
Official Title
A Pilot Study of Diabetes Risk Reduction Program With Overweight WIC Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Weight Gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
lifestyle intervention
Arm Type
Experimental
Arm Description
Control group: usual WIC care
Intervention Type
Other
Intervention Name(s)
lifestyle intervention
Primary Outcome Measure Information:
Title
body weight
Secondary Outcome Measure Information:
Title
dietary fat intake, fruit and vegetable intake, physical activity, stress, affects

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Michigan Stat University College of Nursing
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Michigan State University College of Nursing
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19930587
Citation
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.
Results Reference
derived

Learn more about this trial

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

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