Clinical trial NCT03663621: Prepare - How to Reach Women of Reproductive Age With Obesity to Support Weight Loss Before Pregnancy?
Official title: How to Reach Women of Reproductive Age With Obesity to Support Weight Loss Before Pregnancy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Pregnancy Complications
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2018-09-10
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include patients in Massachusetts General Hospital clinical settings, users of the Ovia fertility app as well as members of the community who may see ads posted in local newspapers.

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.

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

Primary outcomes:
measure: Participant recruitment feasibility
timeFrame: 1 year
Secondary outcomes:
measure: Participants' attitudes and perceptions of their own health risks with regard to weight-related complications
timeFrame: 1 year
measure: Participant adherence during a structured weight loss program.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Pilgrim Health Care Institute
state: Massachusetts
Study officials:
affiliation: Harvard Pilgrim Health Care Institute
name: Marie-France Hivert, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: