NCT01096888

Brief Summary

The purpose of this study is to provide weight loss interventions for Mothers participating in the WIC program, using the internet to deliver weight loss materials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2010

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

March 30, 2010

Last Update Submit

October 26, 2015

Conditions

Keywords

WICWeight lossOverweightPost PartumInternet based weight loss intervention for Mothers in the WIC program.

Outcome Measures

Primary Outcomes (1)

  • Enhanced WIC program to instigate weight loss

    We are taking the standard WIC care for Mothers who are at least 6 months post partum and enhancing their program to include an internet based weight loss intervention.

    3 months

Secondary Outcomes (1)

  • Baseline characteristics that moderate the efficacy of the intervention.

    3 months

Study Arms (2)

Standard WIC care

NO INTERVENTION

Patients randomized to this group will receive standard WIC care and an information packet surround healthy eating and activity topics.

Enhanced WIC weight loss program

ACTIVE COMPARATOR

Participants randomized into this condition will receive standard WIC care, but will also receive weight loss classes provided through the internet. Topics will cover behavioral weight loss topics, based off the protocols of the Look AHEAD program.

Behavioral: Enhanced WIC Program

Interventions

Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.

Enhanced WIC weight loss program

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years.
  • Delivery within 6-52 weeks
  • Exceed pre-pregnancy weight by at least 6.8 kg (15 pounds)
  • Current BMI \> 22
  • English speaking
  • Has computer with internet access
  • Literacy of at least 5th grade reading level

You may not qualify if:

  • Pregnant or planning to become pregnant
  • Relocating in the next year
  • Serious medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

Location

MeSH Terms

Conditions

Weight LossOverweight

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Suzanne Phelan, PhD.

    California Polytechnic State University-San Luis Obispo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2010

First Posted

March 31, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations