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Clinical Trials/NCT03663621
NCT03663621
Completed
Not Applicable

How to Reach Women of Reproductive Age With Obesity to Support Weight Loss Before Pregnancy?

Harvard Pilgrim Health Care1 site in 1 country99 target enrollmentJanuary 25, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Harvard Pilgrim Health Care
Enrollment
99
Locations
1
Primary Endpoint
Participant recruitment feasibility
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Researchers at Harvard Pilgrim Health Care Institute and Massachusetts General Hospital are conducting a study to learn more about how best to reach out to women (age 18-45) who are thinking about a pregnancy in the next couple of years and currently have a BMI greater than 30 kg/m2.

Interested participants will be asked to complete a 15-minute survey. The survey will ask some more questions about their prior reproductive health history, opinions and experiences regarding lifestyle, weight and health. After completing the survey, researchers would like to arrange a time to complete a 20- to 30-minute semi-structured interview about their perceived health in the process of planning pregnancy.

Detailed Description

The purpose of this study is to learn the best ways to support healthful behaviors and weight loss prior to pregnancy. Researchers are also interested in what motivates or prevents women of reproductive age from engaging in a structured weight loss program. Participants will be asked for no more than an hour of their time to complete a brief survey and participate in an interview. This study is being conducted by Harvard Pilgrim Health Care Institute. This study is being paid for by the Nutrition Obesity Research Center at Harvard (NORCH). At the end of the interview, study staff will also talk to participants about the opportunity to be referred to the Mass General Weight Center if they are interested in participating in a program now being offered there. If participants elect to participate in a program at the weight center, researchers would then like to complete 2 more short interviews with these participants about that process. The first will be about 5 minutes and will take place just after the initial Weight Center Orientation, and the last will be about 10 minutes and take place after 3 months of participation. During this final interview, researchers will ask for participant opinions about the program that they have just participated in.

Registry
clinicaltrials.gov
Start Date
January 25, 2018
End Date
June 15, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women aged 18-45 years old,
  • BMI\>30 mg/m2,
  • thinking about planning a pregnancy in the next 2 years

Exclusion Criteria

  • Previous bariatric surgery,
  • currently pregnant

Outcomes

Primary Outcomes

Participant recruitment feasibility

Time Frame: 1 year

Feasibility determined by compiling the actual number of participants recruited divided by the time and resources necessary to achieve that number participants for each recruitment strategy.

Secondary Outcomes

  • Participants' attitudes and perceptions of their own health risks with regard to weight-related complications(1 year)
  • Participant adherence during a structured weight loss program.(1 year)
  • Participants' estimated time frame before trying to get pregnant and willingness to delay their pregnancy attempt in order to complete a structured weight loss program.(1 year)

Study Sites (1)

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