Gestational Weight Gain, Maternal Fat Accretion, Infant Fat Accretion
Conditions
Keywords
Fat mass, Gestational weight gain, Infant fat mass, High fiber, Microbiome
Brief summary
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.
Interventions
BEHAVIORALHigh 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.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Weight Changes | Baseline through 2-mounths postpartum | Assess weight change between groups |
| Maternal Fat Accretion Changes | Baseline through 2-mounths postpartum | Assess fat accretion change between groups using the Selinger four-compartment model |
| Identify Changes in Fiber Intake | Baseline through 2-months postpartum | Compare fiber intake between groups by using 24-hour dietary recalls |
| Identify Changes in Dietary Quality | Baseline through 2-months postpartum | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant Fat Accrual | Birth to 12-month old | 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 |
| Dietary Quality | 2-months through 12-months postpartum | 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). |
| Maternal Weight | 2-months through 12-months postpartum | Assess weight change |
| Maternal Fat Accretion | 2-months through 12-months postpartum | Assess fat accretion change between groups using the Selinger four-compartment model |
| Dietary Fiber Intake | 2-months through 12-months postpartum | Assess differences using 24h recalls |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Women in the usual care group, will received standard care from the obstetrician. | 24 |
| 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. | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Usual Care | Total | High Fiber |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 48 Participants | 24 Participants |
| Age, Continuous | 31.92 years STANDARD_DEVIATION 4.86 | 30.85 years STANDARD_DEVIATION 4.81 | 29.79 years STANDARD_DEVIATION 4.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 42 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pre-pregnancy Body Mass Index (BMI) | 26.33 kg/m^2 STANDARD_DEVIATION 4.95 | 25.62 kg/m^2 STANDARD_DEVIATION 4.52 | 24.92 kg/m^2 STANDARD_DEVIATION 4.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 37 Participants | 18 Participants |
| Region of Enrollment United States | 24 participants | 48 participants | 24 participants |
| Sex: Female, Male Female | 24 Participants | 48 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
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).
Time frame: Baseline through 2-months postpartum
Population: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Identify Changes in Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at Baseline | 54.59 AHEI score | Standard Deviation 9.82 |
| Usual Care | Identify Changes in Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at End of Pregnancy | 50.06 AHEI score | Standard Deviation 11.34 |
| Usual Care | Identify Changes in Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at 2mo postpartum | 51.43 AHEI score | Standard Deviation 10.34 |
| High Fiber | Identify Changes in Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at Baseline | 62.51 AHEI score | Standard Deviation 10.95 |
| High Fiber | Identify Changes in Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at End of Pregnancy | 70.12 AHEI score | Standard Deviation 12.41 |
| High Fiber | Identify Changes in Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at 2mo postpartum | 62.53 AHEI score | Standard Deviation 9.33 |
Primary
Identify Changes in Fiber Intake
Compare fiber intake between groups by using 24-hour dietary recalls
Time frame: Baseline through 2-months postpartum
Population: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Identify Changes in Fiber Intake | Total Dietary Fiber Intake at Baseline (g/day) | 19.01 g/day | Standard Deviation 3.88 |
| Usual Care | Identify Changes in Fiber Intake | Total Dietary Fiber Intake at End of Pregnancy (g/day) | 19.35 g/day | Standard Deviation 8.05 |
| Usual Care | Identify Changes in Fiber Intake | Total Dietary Fiber Intake at 2mo postpartum (g/day) | 19.62 g/day | Standard Deviation 6.78 |
| High Fiber | Identify Changes in Fiber Intake | Total Dietary Fiber Intake at Baseline (g/day) | 21.84 g/day | Standard Deviation 7.51 |
| High Fiber | Identify Changes in Fiber Intake | Total Dietary Fiber Intake at End of Pregnancy (g/day) | 35.09 g/day | Standard Deviation 7.37 |
| High Fiber | Identify Changes in Fiber Intake | Total Dietary Fiber Intake at 2mo postpartum (g/day) | 29.71 g/day | Standard Deviation 10.63 |
Primary
Maternal Fat Accretion Changes
Assess fat accretion change between groups using the Selinger four-compartment model
Time frame: Baseline through 2-mounths postpartum
Population: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Maternal Fat Accretion Changes | Percent Fat Mass at Baseline | 33.49 percent fat mass | Standard Deviation 5.96 |
| Usual Care | Maternal Fat Accretion Changes | Percent Fat Mass at End of Pregnancy | 36.74 percent fat mass | Standard Deviation 5.05 |
| Usual Care | Maternal Fat Accretion Changes | Percent Fat Mass at 2mo postpartum | 36.35 percent fat mass | Standard Deviation 5.95 |
| High Fiber | Maternal Fat Accretion Changes | Percent Fat Mass at Baseline | 32.27 percent fat mass | Standard Deviation 5.18 |
| High Fiber | Maternal Fat Accretion Changes | Percent Fat Mass at End of Pregnancy | 34.91 percent fat mass | Standard Deviation 4.33 |
| High Fiber | Maternal Fat Accretion Changes | Percent Fat Mass at 2mo postpartum | 34.38 percent fat mass | Standard Deviation 5.65 |
Primary
Maternal Weight Changes
Assess weight change between groups
Time frame: Baseline through 2-mounths postpartum
Population: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Maternal Weight Changes | Weight at Baseline (kg) | 70.20 kg | Standard Deviation 10.44 |
| Usual Care | Maternal Weight Changes | Weight at End of Pregnancy (kg) | 80.12 kg | Standard Deviation 10 |
| Usual Care | Maternal Weight Changes | Weight at 2mo postpartum (kg) | 73.53 kg | Standard Deviation 10.04 |
| High Fiber | Maternal Weight Changes | Weight at Baseline (kg) | 66.47 kg | Standard Deviation 7.04 |
| High Fiber | Maternal Weight Changes | Weight at End of Pregnancy (kg) | 75.80 kg | Standard Deviation 6.89 |
| High Fiber | Maternal Weight Changes | Weight at 2mo postpartum (kg) | 67.99 kg | Standard Deviation 7.36 |
Secondary
Dietary Fiber Intake
Assess differences using 24h recalls
Time frame: 2-months through 12-months postpartum
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Dietary Fiber Intake | Total Dietary Fiber Intake at 6mo postpartum | 19.48 g/day | Standard Deviation 6.72 |
| Usual Care | Dietary Fiber Intake | Total Dietary Fiber Intake at 12mo postpartum | 17.87 g/day | Standard Deviation 6.31 |
| High Fiber | Dietary Fiber Intake | Total Dietary Fiber Intake at 6mo postpartum | 26.94 g/day | Standard Deviation 7.58 |
| High Fiber | Dietary Fiber Intake | Total Dietary Fiber Intake at 12mo postpartum | 23.80 g/day | Standard Deviation 7.13 |
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).
Time frame: 2-months through 12-months postpartum
Population: Between the 2mo and 12mo timepoint, one participant withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at 6mo postpartum | 49.47 AHEI score | Standard Deviation 11.72 |
| Usual Care | Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at 12mo postpartum | 48.66 AHEI score | Standard Deviation 12.14 |
| High Fiber | Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at 6mo postpartum | 66.05 AHEI score | Standard Deviation 13.69 |
| High Fiber | Dietary Quality | Alternative Healthy Eating Index (AHEI) Total Score at 12mo postpartum | 61.59 AHEI score | Standard Deviation 10.11 |
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
Time frame: Birth to 12-month old
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Infant Fat Accrual | Percent Fat Mass at 2-weeks | 17.20 percent fat mass | Standard Deviation 2.52 |
| Usual Care | Infant Fat Accrual | Percent Fat Mass at 12-months | 34.89 percent fat mass | Standard Deviation 3.16 |
| High Fiber | Infant Fat Accrual | Percent Fat Mass at 12-months | 32.62 percent fat mass | Standard Deviation 3.57 |
| High Fiber | Infant Fat Accrual | Percent Fat Mass at 2-weeks | 17.26 percent fat mass | Standard Deviation 3.23 |
Secondary
Maternal Fat Accretion
Assess fat accretion change between groups using the Selinger four-compartment model
Time frame: 2-months through 12-months postpartum
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Maternal Fat Accretion | Percent Fat Mass at 6mo postpartum | 34.79 percent fat mass | Standard Deviation 8.19 |
| Usual Care | Maternal Fat Accretion | Percent Fat Mass at 12mo postpartum | 33.69 percent fat mass | Standard Deviation 9.09 |
| High Fiber | Maternal Fat Accretion | Percent Fat Mass at 6mo postpartum | 30.92 percent fat mass | Standard Deviation 5.28 |
| High Fiber | Maternal Fat Accretion | Percent Fat Mass at 12mo postpartum | 30.81 percent fat mass | Standard Deviation 6.76 |
Secondary
Maternal Weight
Assess weight change
Time frame: 2-months through 12-months postpartum
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Maternal Weight | Weight at 6mo postpartum (kg) | 71.67 kg | Standard Deviation 11.87 |
| Usual Care | Maternal Weight | Weight at 12mo postpartum (kg) | 71.65 kg | Standard Deviation 11.56 |
| High Fiber | Maternal Weight | Weight at 6mo postpartum (kg) | 65.53 kg | Standard Deviation 8.07 |
| High Fiber | Maternal Weight | Weight at 12mo postpartum (kg) | 64.58 kg | Standard Deviation 8.3 |