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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Women in the usual care group, will received standard care from the obstetrician. | |
| High fiber | Experimental | Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High fiber diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Weight Changes | Assess weight change between groups | Baseline through 2-mounths postpartum |
| Maternal Fat Accretion Changes | Assess fat accretion change between groups using the Selinger four-compartment model | Baseline through 2-mounths postpartum |
| Identify Changes in Fiber Intake | Compare fiber intake between groups by using 24-hour dietary recalls | Baseline through 2-months postpartum |
| Identify Changes in Dietary Quality | Compare dietary quality between groups using the Alternative Healthy Eating Index (AHEI) scoring ranges from 0 to 100 (higher score means a better diet quality). | Baseline through 2-months postpartum |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Hull, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38145714 | Derived | Herman A, Hand LK, Gajewski B, Krase K, Sullivan DK, Goetz J, Hull HR. A high fiber diet intervention during pregnancy: The SPROUT (Single goal in PRegnancy to optimize OUTcomes) protocol paper. Contemp Clin Trials. 2024 Feb;137:107420. doi: 10.1016/j.cct.2023.107420. Epub 2023 Dec 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Women in the usual care group, will received standard care from the obstetrician. |
| FG001 | High Fiber | Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks. High fiber diet: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Three participants withdrew from the study after enrolling, but prior to the baseline visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Women in the usual care group, will received standard care from the obstetrician. |
| BG001 | High Fiber | Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks. High fiber diet: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Weight Changes | Assess weight change between groups | Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy. | Posted | Mean | Standard Deviation | kg | Baseline through 2-mounths postpartum |
|
Adverse event data was tracked and monitored from baseline (12-20 weeks gestation) until 30 days post invention (up to 2 weeks postpartum).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Women in the usual care group, will received standard care from the obstetrician. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holly Hull | University of Kansas Medical Center | 9135881000 | hhull@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2022 | May 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2022 | May 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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Women in the control group will participate in weekly lessons for 18 weeks on eating a high fiber diet and will received daily snacks.
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Assess weight change
| 2-months through 12-months postpartum |
| Maternal Fat Accretion | Assess fat accretion change between groups using the Selinger four-compartment model | 2-months through 12-months postpartum |
| Dietary Fiber Intake | Assess differences using 24h recalls | 2-months through 12-months postpartum |
| Dietary Quality | Compare dietary quality between groups using the Alternative Healthy Eating Index (AHEI) scoring ranges from 0 to 100 (higher score means a better diet quality). | 2-months through 12-months postpartum |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Pre-pregnancy Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
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| Primary | Maternal Fat Accretion Changes | Assess fat accretion change between groups using the Selinger four-compartment model | Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy. | Posted | Mean | Standard Deviation | percent fat mass | Baseline through 2-mounths postpartum |
|
|
|
| Primary | Identify Changes in Fiber Intake | Compare fiber intake between groups by using 24-hour dietary recalls | Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy. | Posted | Mean | Standard Deviation | g/day | Baseline through 2-months postpartum |
|
|
|
| Primary | Identify Changes in Dietary Quality | Compare dietary quality between groups using the Alternative Healthy Eating Index (AHEI) scoring ranges from 0 to 100 (higher score means a better diet quality). | Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy. | Posted | Mean | Standard Deviation | AHEI score | Baseline through 2-months postpartum |
|
|
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| Secondary | 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 | Of the participants that completed the 2-week and 12-month visits, many refused or were uncooperative during the DXA scan. And even a higher percentage were deemed unusable scans due to infant movement. | Posted | Mean | Standard Deviation | percent fat mass | Birth to 12-month old |
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| Secondary | Maternal Weight | Assess weight change | Between the 2mo and 12mo timepoint, one participant withdrew from high fiber group of the study (Baseline to 2mo postpartum, Usual care: 15, High Fiber:16). | Posted | Mean | Standard Deviation | kg | 2-months through 12-months postpartum |
|
|
|
| Secondary | Maternal Fat Accretion | Assess fat accretion change between groups using the Selinger four-compartment model | Between the 2mo and 12mo timepoint, one participant withdrew from high fiber group of the study (Baseline to 2mo postpartum, Usual care: 15, High Fiber:16). | Posted | Mean | Standard Deviation | percent fat mass | 2-months through 12-months postpartum |
|
|
|
| Secondary | Dietary Fiber Intake | Assess differences using 24h recalls | Between the 2mo and 12mo timepoint, one participant withdrew from high fiber group of the study (Baseline to 2mo postpartum, Usual care: 15, High Fiber:16). | Posted | Mean | Standard Deviation | g/day | 2-months through 12-months postpartum |
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| Secondary | Dietary Quality | Compare dietary quality between groups using the Alternative Healthy Eating Index (AHEI) scoring ranges from 0 to 100 (higher score means a better diet quality). | Between the 2mo and 12mo timepoint, one participant withdrew from the study | Posted | Mean | Standard Deviation | AHEI score | 2-months through 12-months postpartum |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | High Fiber | Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks. High fiber diet: 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Percent Fat Mass at 2mo postpartum |
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| Total Dietary Fiber Intake at 2mo postpartum (g/day) |
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| Alternative Healthy Eating Index (AHEI) Total Score at 2mo postpartum |
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