NCT02176915

Brief Summary

The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

4.4 years

First QC Date

June 25, 2014

Last Update Submit

October 11, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index from baseline

    3 months, 12 months

Secondary Outcomes (2)

  • Change in Pregnancy Physical Activity Questionnaire score from baseline

    3 months, 12 months

  • Change in 24-hour dietary recall from baseline

    3 months, 12 months

Study Arms (2)

Group program

EXPERIMENTAL

8-session group weight loss program and 4 follow-up phone counseling sessions

Behavioral: Group program

Print Materials

ACTIVE COMPARATOR

8 weekly mailings of print materials covering weight loss topics through US mail.

Behavioral: Print Materials

Interventions

Group programBEHAVIORAL
Group program
Print MaterialsBEHAVIORAL
Print Materials

Eligibility Criteria

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

You may qualify if:

  • months or less postpartum
  • Speaks English
  • BMI 25 or greater
  • Client of WIC program, Worcester MA

You may not qualify if:

  • Not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • Rosal MC, Haughton CF, Estabrook BB, Wang ML, Chiriboga G, Nguyen OH, Person SD, Lemon SC. Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial. BMC Public Health. 2016 Sep 9;16(1):953. doi: 10.1186/s12889-016-3520-0.

    PMID: 27612615DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephenie Lemon, PhD

    UMass Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 27, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2018

Study Completion

September 1, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Locations

US(1)