Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion

Study Overview
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Brief Summary
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The purpose of this study is to learn if consuming a high fiber diet will reduce gestational weight gain and maternal and infant fat accretion.

Official Title
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Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion by Increasing Fiber Intake and Changing the Maternal Microbiome During Pregnancy

Conditions
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Gestational Weight Gain, Maternal Fat Accretion, Infant Fat Accretion

Intervention / Treatment
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* Behavioral: High fiber diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-pregnancy BMI 18.5 - 45.0 kg/m2 Exclusion Criteria: Comsuming more than 20 g/day of fiber No phone and internet access Pre-gestational diabetes Diagnosed with diabetes Pre-eclampsia Hypertension Other metabolic abnormalities Asthma Heart disease Smoking Drug abuse Recent antibiotic use Pregnancies of multiples

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women in the control group will participate in weekly lessons for 18 weeks on eating a high fiber diet and will received daily snacks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Women in the usual care group, will received standard care from the obstetrician. | |
| Experimental: High fiber<br>Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks. | Behavioral: High fiber diet<br>* A registered dietitian will delivered the lessons on consuming a high fiber diet to small groups to increased engage and material retention. These lessons will last 18 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal weight and fat accretion changes | Assess weight and fat accretion change between groups using the Selinger four-compartment model | Baseline through 2-mounths postpartum | 
| Identify changes in fiber intake and dietary quality | Compare fiber intake and dietary quality between groups by using 24-hour dietary recalls | Baseline through 2-months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant fat accrual | Identify differences in early infant fat accrual between group by completing body composition measurements including but not limited to Dual energy x-ray absorptiometry (DXA) and PeaPod | Birth to 12-month old | 
| Maternal weight and fat accretion | Assess weight and fat accretion change between groups using the Selinger four-compartment model | 2-months through 12-months postpartum | 
| Dietary fiber intake and dietary quality | Assess differences using the Alternative Healthy Eating Index (AHEI) | 2-months through 12-months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fat mass, Gestational weight gain, Infant fat mass, High fiber, Microbiome