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NCT Number: NCT03663621

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

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.

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Key information

Conditions

Obesity Body Weight Female Urogenital Diseases and Pregnancy Complications Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Harvard Pilgrim Health Care Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Participants' attitudes and perceptions of their own health risks with regard to weight-related complications

    Time frame: 1 year

    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

  2. Participant adherence during a structured weight loss program.

    Time frame: 1 year

    Participants' attendance is recorded throughout the duration of a 12-week weight loss program. Successful adherents will have attended >70% of meetings.

  3. 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.

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 10, 2018
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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