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

NCT03663621 | Completed

• 1 other identifier: 1105007
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Previous bariatric surgery,
• currently pregnant

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Harvard Pilgrim Health Care Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity; Pregnancy Complications

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie-France Hivert, MD, MMSc

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: September 10, 2018
• Study Start: January 25, 2018
• Primary Completion: August 31, 2019
• Study Completion: June 15, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)