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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663621
• Other study ID #: 1105007
• Status: Completed
• Start date: January 25, 2018
• Est. completion date: June 15, 2020

Study information

• Verified date: June 2020
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 15, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pregnancy Complications
• Weight Loss

Locations

Country	Name	City	State
United States	Harvard Pilgrim Health Care Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant recruitment feasibility	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.	1 year
Secondary	Participants' attitudes and perceptions of their own health risks with regard to weight-related complications	Participants are asked to measure levels of agreement/disagreement with their perceived health risk for ten weight related complications as follows: developing developing diabetes, developing cancer, developing heart disease, developing high blood pressure, developing high cholesterol, being able to get pregnant, having diabetes during pregnancy, having high blood pressure during pregnancy, having a large baby, and having to undergo a c-section	1 year
Secondary	Participant adherence during a structured weight loss program.	Participants' attendance is recorded throughout the duration of a 12-week weight loss program. Successful adherents will have attended >70% of meetings.	1 year
Secondary	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.	Participants are interviewed to assess their current time frame before actively trying to get pregnant. Participants are also asked if they are willing to delay a pregnancy attempt and if so, for how long.	1 year