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Lifestyle Intervention for Preconception Care in Overweight Women

N/A

Recruiting

Led By William D Fraser, MD,MSc

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Woman's body mass index ≥ 25 kg/m2

Be between 18 and 65 years old

Must not have

Prior bariatric surgery

Type 1 or 2 diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 2, 4, and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand if a combination of motivational interviewing and mobile phone follow-ups can help overweight women and their partners adopt healthier lifestyle habits before conception. Additionally, the study will evaluate the impact of the intervention on weight, waist circumference, and body fat percentage of the participants.

Who is the study for?

This trial is for overweight women with a BMI of ≥25 kg/m2 who plan to conceive within the next year, and their partners. They must have access to a smartphone but can't join if they have diabetes, prior weight loss surgery, or conditions affecting weight significantly. Women with infertility issues, eating disorders, or contraindications to pregnancy or exercise are also excluded.

What is being tested?

The study tests whether motivational talks and a mobile app can help couples adopt healthier habits before pregnancy. It tracks changes in women's and partners' weight and body fat. The impact on pregnancy outcomes like complications, delivery mode, and baby's birth weight will be evaluated.

What are the potential side effects?

Since this is a lifestyle intervention involving dieting advice and physical activity rather than medication or medical procedures, side effects may include typical reactions to new exercise routines such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is 25 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had weight loss surgery in the past.

Select...

I have type 1 or type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 2, 4, and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 2, 4, and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 2, 4, and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy. for reporting.