SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04242069

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Healthy for my Baby- A Randomized Controlled Trial Assessing a Preconception Clinically Integrated Technological Intervention to Improve the Lifestyle of Overweight Women and Their Partners

The purpose of this study is to determine whether an intervention combining motivational interviewing and follow-up with a mobile phone application will help overweight women and their partners adopt healthy lifestyle habits in the preconception period. This study will also evaluate the impact of the intervention on the weight, waist circumference, and body fat of women and their partners. Women and their partners will be followed through pregnancy to explore the effects of the intervention on the adequacy of gestational weight gain, rates of pregnancy complications, delivery mode, and infant birth weight.

NCT04242069 Overweight and Obesity Pregnancy Complications Health Behavior Life Style Preconception Care
MeSH:Pregnancy Complications Overweight

2 Interventions

Name: Healthy for my Baby

Description: Participants will start the preconception intervention by meeting with a health professional for a motivational interview session on healthy lifestyle habits. Following this interview, participants will have access to a mobile phone application that will allow them to track daily lifestyle modification goals. After a month, they will meet the health professional for a second motivational interview and review their progression. Participants will continue to make lifestyle changes through the preconception period by accomplishing smart goals followed daily in the mobile phone application. If the woman becomes pregnant, the couple will participate in two more in-person motivational interviews, a month apart. The mobile application will be put in pregnancy mode, and participants will adapt their daily lifestyle goals for the pregnancy. Participants will continue to make lifestyle changes throughout pregnancy by accomplishing smart goals followed daily in the mobile phone application.
Type: Behavioral
Group Labels: 1

Intervention

Name: Usual Care

Description: Participants in the control group will receive standard advice on healthy lifestyle habits as provided by their usual care provider. They will receive standard medical care in preconception and pregnancy. To improve compliance with the study follow-up, participants in this group will have access to a simplified version of the mobile application that contains a fertility calendar and a research visit calendar. This version of the application does not include lifestyle goals or any information on healthy lifestyle habits.
Type: Other
Group Labels: 1

Control


Primary Outcomes

Description: Women's C-HEI score will be measured with two or three online 24 hour dietary recalls (R24W tool) at each time point. Value range 0-100 with a higher score indicating better diet quality. The change of the score in time during the preconception period will be compared between the groups.

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

Time: 0, 2, 4, and 6 months

Secondary Outcomes

Description: Physical activity measured in MET-minutes/week. Value range of 0-5000 MET-minutes/week with a higher score indicating a higher activity level.

Measure: Men and Women's physical activity level measured with the International Physical Activity Questionnaires Short Version.

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: Steps per day measured with a wristband accelerometer over 7 days . Value range 0- 15 000 steps per day with a higher step count indicating a higher activity level.

Measure: Men and Women's steps per day measured with a Fitbit.

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: Minutes of moderate and vigorous physical activity per week measured with a wristband accelerometer over 7 days. Value range 0-800 minutes with a higher number of minutes indicating a higher activity level.

Measure: Men and Women's minutes of moderate and vigorous physical activity measured with a Fitbit.

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: Sleep quality measured with a questionnaire. Value range 0-21 with a higher score indicating lower sleep quality.

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

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: Quality of life measured with a questionnaire and reported as a t-score. Value range 0-100 with a higher score indicating better quality of life.

Measure: Men and Women's quality of life measured with the SF-12 v2

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: Anxiety and Depression symptoms measured with a questionnaire. Value range 0-42 with a higher score indicating more anxiety and depression symptoms.

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

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: The change in body fat will be assessed in preconception using foot-to-foot bioimpedance.

Measure: Women's body fat percentage.

Time: 0, 3, and 6 months in preconception.

Description: The change in waist circumference will be assessed in preconception using a measuring tape and a standardized protocol.

Measure: Women's waist circumference in centimeters.

Time: 0, 3, and 6 months in preconception.

Description: The change in bodyweight will be assessed throughout the study using a calibrated scale.

Measure: Men and Women's weight in kilograms.

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: The change in body fat will be assessed throughout the study using foot-to-foot bioimpedance.

Measure: Men's body fat percentage.

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: The change in waist circumference will be assessed throughout the study using a measuring tape and a standardized protocol.

Measure: Men's waist circumference in centimeters.

Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: Women's C-HEI score will be measured with two or three online 24 hour dietary recalls at each time point (R24W tool). Value range 0-100 with a higher score indicating better diet quality.

Measure: Women's diet quality in pregnancy measured with the Canadian-Healthy Eating Index- 2007.

Time: 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.

Description: Women's total weight gain in pregnancy will be obtained from their medical file. The proportion of adequate gestational weight gain according to BMI specific recommendations (IOM, 2009) will be compared between groups.

Measure: Proportion of adequate gestational weight gain

Time: At delivery.

Description: Rates of gestational diabetes (diagnosed with a provoked hyperglycemia test or serial capillary glycemia measures), gestational hypertension (clinical diagnosis), pre-eclampsia (clinical diagnosis), fetal macrosomia (birth weight over the 90th percentile for the gestational age and sex), and mode of delivery.

Measure: Rate of pregnancy complications

Time: At delivery.

Other Outcomes

Description: Rates of clinical pregnancies (embryo with a positive heartbeat on first trimester ultrasound), spontaneous miscarriage (unviable pregnancy prior to 20 weeks of gestation), and live birth rate.

Measure: Fertility outcomes

Time: After 9 months of follow-up.

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 R24W

Women's C-HEI score will be measured with two or three online 24 hour dietary recalls (R24W tool) at each time point. --- R24W ---

The change in waist circumference will be assessed throughout the study using a measuring tape and a standardized protocol.. Women's diet quality in pregnancy measured with the Canadian-Healthy Eating Index- 2007.. Women's C-HEI score will be measured with two or three online 24 hour dietary recalls at each time point (R24W tool). --- R24W ---



HPO Nodes