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

NCT ID: NCT03663621

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2020-06-15

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.

Conditions

Obesity; Pregnancy Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Initial survey and interview (Aim 2)

Participants in Aim 2 will be asked to complete an initial 15-minute survey and 20-30 minute semi-structured interview. 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.

No interventions assigned to this group

Formal weight loss program (Aim 3)

Participants in Aim 3 have expressed interest in referral to the Mass General Weight Center. The purpose of this study is to learn what motivates or prevents women of reproductive age from engaging in a structured weight loss program. Researchers will ask for no more than a half hour of participant's time to complete a 5- minute interview following Orientation at the Weight Center and another 10-minute interview after a participant has participated in a program offered at the Weight Center.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-France Hivert, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Harvard Pilgrim Health Care Institute

Locations

Harvard Pilgrim Health Care Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1105007

Identifier Type: -

Identifier Source: org_study_id