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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

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

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 2007

Secondary outcome measures

Men and Women's Anxiety and Depression symptoms measured with the Hospital Anxiety and Depression Scale.

Men and Women's Sleep quality measured with the Pittsburgh Sleep Quality Index

Men and Women's diet quality measured with the Canadian-Healthy Eating Index- 2007.

+12 more

Other outcome measures

Fertility outcomes

Trial Design

2Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Healthy for my Baby Intervention

Group II: ControlExperimental Treatment1 Intervention

Usual care

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor

292 Previous Clinical Trials

69,373 Total Patients Enrolled

William D Fraser, MD,MScPrincipal InvestigatorResearcher, Centre de recherche du CHUS

Media Library

Healthy for my Baby Clinical Trial Eligibility Overview. Trial Name: NCT04242069 — N/A

Preconception Care Research Study Groups: Control, Intervention

Preconception Care Clinical Trial 2023: Healthy for my Baby Highlights & Side Effects. Trial Name: NCT04242069 — N/A

Healthy for my Baby 2023 Treatment Timeline for Medical Study. Trial Name: NCT04242069 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must prospective participants meet in order to join this experiment?

"In order to be eligible for this medical trial, individuals must have healthy habits and fall between the ages of 18 and 40. Presently, 68 participants are sought after by researchers."

Answered by AI

How many participants can take part in this experimental research?

"Indeed, the information available on clinicaltrials.gov states that this medical study is actively recruiting participants. The trial was first advertised on June 18th 2021 and most recently updated on October 31st 2022; in total 68 patients need to be enrolled from 2 different locations."

Answered by AI

Does this experiment permit individuals aged twenty or more to participate?

"This medical trial is open to those aged between 18 and 40 years old. For younger individuals, there are 87 studies available while 297 can be found for older patients."

Answered by AI

Is there still capacity for participants to join this trial?

"Affirmative. Information available on clinicaltrials.gov suggests that this research study is actively searching for participants, having been first published on June 18th 2021 and amended lastly October 31st 2022. 68 volunteers are needed between 2 different sites."

Answered by AI

Recent research and studies

Experimental Diabetes ResearchJournal

Intergenerational Cycle of Obesity and Diabetes: How Can We Reduce the Burdens of These Conditions on the Health of Future Generations?

Battista, Marie-Claude, Marie-France Hivert, Karine Duval, and Jean-Patrice Baillargeon. 2011. “Intergenerational Cycle of Obesity and Diabetes: How Can We Reduce the Burdens of These Conditions on the Health of Future Generations?”. Experimental Diabetes Research. Hindawi Limited. doi:10.1155/2011/596060.

Frontiers in Public HealthJournal

Healthy for My Baby Research Protocol- a Randomized Controlled Trial Assessing a Preconception Intervention to Improve the Lifestyle of Overweight Women and Their Partners

Hardy, Isabelle, Amanda Lloyd, Anne-Sophie Morisset, Felix Camirand Lemyre, Jean-Patrice Baillargeon, and William D. Fraser. 2021. “Healthy for My Baby Research Protocol- a Randomized Controlled Trial Assessing a Preconception Intervention to Improve the Lifestyle of Overweight Women and Their Partners”. Frontiers in Public Health. Frontiers Media SA. doi:10.3389/fpubh.2021.670304.

Obesity ReviewsJournal

Risks Associated with Obesity in Pregnancy, for the Mother and Baby: A Systematic Review of Reviews

Marchi, J., M. Berg, A. Dencker, E. K. Olander, and C. Begley. 2015. “Risks Associated with Obesity in Pregnancy, for the Mother and Baby: A Systematic Review of Reviews”. Obesity Reviews. Wiley. doi:10.1111/obr.12288.

Journal of the American Dietetic AssociationJournal