Nutrition and exercise program for pregnant individuals with choice of intervention
A Participant Choice Approach to Improve Adherence and Investigate Pregnancy Outcomes to Lifestyle Interventions
NA · Western University, Canada · NCT06187675
This study is testing whether letting pregnant individuals choose their nutrition and exercise plans can help them manage weight gain and improve their health during pregnancy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Western University, Canada (other) |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06187675 on ClinicalTrials.gov |
What this trial studies
This intervention program aims to address excessive gestational weight gain by offering pregnant individuals a choice between different nutrition and exercise strategies. Participants will be randomly assigned to either a choice group, where they can select from three intervention strategies, or a no-choice group, where they will be matched to a participant with a choice. The program includes a modified gestational diabetic meal plan and structured exercise components, all designed to promote adherence and improve pregnancy health outcomes. The study will evaluate the impact of participant choice on adherence and health outcomes throughout the pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals between 12 to 18 weeks gestation with a singleton fetus who can safely participate in exercise.
Not a fit: Patients with serious medical conditions, high blood pressure, or contraindications to exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance adherence to lifestyle interventions during pregnancy, leading to better health outcomes for both mothers and their babies.
How similar studies have performed: Other studies have shown that personalized approaches to lifestyle interventions can improve adherence, suggesting potential success for this novel choice-based strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * between 12 to 18 weeks of pregnancy * a singleton fetus * medically screened with the Get Active Questionnaire for Pregnancy to determine eligibility for participation in the exercise component Exclusion Criteria: * inability to walk * serious medical problems * high blood pressure * uncontrolled chest pain * uncontrolled symptomatic lung disease * diabetes before pregnancy * a history of recreational substance use disorder * any contraindication to exercise * enrolled in another clinical trial.
Where this trial is running
London, Ontario
- Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Michelle F Mottola, PhD — Western University
- Study coordinator: Michelle F Mottola, PhD
- Email: mmottola@uwo.ca
- Phone: 519-661-2111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lifestyle, Healthy, Pregnancy Related, Adherence, Treatment, Nutrition, Healthy, Weight Gain, Maternal, pregnancy, lifestyle, nutrition