Trial Outcomes & Findings for Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion (NCT NCT04868110)
NCT ID: NCT04868110
Last Updated: 2025-01-27
Results Overview
Assess weight change between groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline through 2-mounths postpartum
Results posted on
2025-01-27
Participant Flow
Participant milestones
| Measure |
Usual Care
Women in the usual care group, will received standard care from the obstetrician.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Usual Care
Women in the usual care group, will received standard care from the obstetrician.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion
Baseline characteristics by cohort
| Measure |
Usual Care
n=24 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=24 Participants
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.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
31.92 years
STANDARD_DEVIATION 4.86 • n=99 Participants
|
29.79 years
STANDARD_DEVIATION 4.62 • n=107 Participants
|
30.85 years
STANDARD_DEVIATION 4.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
24 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Pre-pregnancy Body Mass Index (BMI)
|
26.33 kg/m^2
STANDARD_DEVIATION 4.95 • n=99 Participants
|
24.92 kg/m^2
STANDARD_DEVIATION 4.03 • n=107 Participants
|
25.62 kg/m^2
STANDARD_DEVIATION 4.52 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline through 2-mounths postpartumPopulation: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.
Assess weight change between groups
Outcome measures
| Measure |
Usual Care
n=15 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=16 Participants
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.
|
|---|---|---|
|
Maternal Weight Changes
Weight at Baseline (kg)
|
70.20 kg
Standard Deviation 10.44
|
66.47 kg
Standard Deviation 7.04
|
|
Maternal Weight Changes
Weight at End of Pregnancy (kg)
|
80.12 kg
Standard Deviation 10.00
|
75.80 kg
Standard Deviation 6.89
|
|
Maternal Weight Changes
Weight at 2mo postpartum (kg)
|
73.53 kg
Standard Deviation 10.04
|
67.99 kg
Standard Deviation 7.36
|
PRIMARY outcome
Timeframe: Baseline through 2-mounths postpartumPopulation: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.
Assess fat accretion change between groups using the Selinger four-compartment model
Outcome measures
| Measure |
Usual Care
n=15 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=16 Participants
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.
|
|---|---|---|
|
Maternal Fat Accretion Changes
Percent Fat Mass at 2mo postpartum
|
36.35 percent fat mass
Standard Deviation 5.95
|
34.38 percent fat mass
Standard Deviation 5.65
|
|
Maternal Fat Accretion Changes
Percent Fat Mass at Baseline
|
33.49 percent fat mass
Standard Deviation 5.96
|
32.27 percent fat mass
Standard Deviation 5.18
|
|
Maternal Fat Accretion Changes
Percent Fat Mass at End of Pregnancy
|
36.74 percent fat mass
Standard Deviation 5.05
|
34.91 percent fat mass
Standard Deviation 4.33
|
PRIMARY outcome
Timeframe: Baseline through 2-months postpartumPopulation: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.
Compare fiber intake between groups by using 24-hour dietary recalls
Outcome measures
| Measure |
Usual Care
n=15 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=16 Participants
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.
|
|---|---|---|
|
Identify Changes in Fiber Intake
Total Dietary Fiber Intake at Baseline (g/day)
|
19.01 g/day
Standard Deviation 3.88
|
21.84 g/day
Standard Deviation 7.51
|
|
Identify Changes in Fiber Intake
Total Dietary Fiber Intake at End of Pregnancy (g/day)
|
19.35 g/day
Standard Deviation 8.05
|
35.09 g/day
Standard Deviation 7.37
|
|
Identify Changes in Fiber Intake
Total Dietary Fiber Intake at 2mo postpartum (g/day)
|
19.62 g/day
Standard Deviation 6.78
|
29.71 g/day
Standard Deviation 10.63
|
PRIMARY outcome
Timeframe: Baseline through 2-months postpartumPopulation: Thirteen participants were removed from the analysis due to a diagnosis of gestational hypertension or hypertensive disorder of pregnancy.
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).
Outcome measures
| Measure |
Usual Care
n=15 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=16 Participants
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.
|
|---|---|---|
|
Identify Changes in Dietary Quality
Alternative Healthy Eating Index (AHEI) Total Score at 2mo postpartum
|
51.43 AHEI score
Standard Deviation 10.34
|
62.53 AHEI score
Standard Deviation 9.33
|
|
Identify Changes in Dietary Quality
Alternative Healthy Eating Index (AHEI) Total Score at Baseline
|
54.59 AHEI score
Standard Deviation 9.82
|
62.51 AHEI score
Standard Deviation 10.95
|
|
Identify Changes in Dietary Quality
Alternative Healthy Eating Index (AHEI) Total Score at End of Pregnancy
|
50.06 AHEI score
Standard Deviation 11.34
|
70.12 AHEI score
Standard Deviation 12.41
|
SECONDARY outcome
Timeframe: Birth to 12-month oldPopulation: 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.
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
Outcome measures
| Measure |
Usual Care
n=10 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=11 Participants
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.
|
|---|---|---|
|
Infant Fat Accrual
Percent Fat Mass at 2-weeks
|
17.20 percent fat mass
Standard Deviation 2.52
|
17.26 percent fat mass
Standard Deviation 3.23
|
|
Infant Fat Accrual
Percent Fat Mass at 12-months
|
34.89 percent fat mass
Standard Deviation 3.16
|
32.62 percent fat mass
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: 2-months through 12-months postpartumPopulation: 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).
Assess weight change
Outcome measures
| Measure |
Usual Care
n=15 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=15 Participants
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.
|
|---|---|---|
|
Maternal Weight
Weight at 6mo postpartum (kg)
|
71.67 kg
Standard Deviation 11.87
|
65.53 kg
Standard Deviation 8.07
|
|
Maternal Weight
Weight at 12mo postpartum (kg)
|
71.65 kg
Standard Deviation 11.56
|
64.58 kg
Standard Deviation 8.30
|
SECONDARY outcome
Timeframe: 2-months through 12-months postpartumPopulation: 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).
Assess fat accretion change between groups using the Selinger four-compartment model
Outcome measures
| Measure |
Usual Care
n=15 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=15 Participants
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.
|
|---|---|---|
|
Maternal Fat Accretion
Percent Fat Mass at 6mo postpartum
|
34.79 percent fat mass
Standard Deviation 8.19
|
30.92 percent fat mass
Standard Deviation 5.28
|
|
Maternal Fat Accretion
Percent Fat Mass at 12mo postpartum
|
33.69 percent fat mass
Standard Deviation 9.09
|
30.81 percent fat mass
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: 2-months through 12-months postpartumPopulation: 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).
Assess differences using 24h recalls
Outcome measures
| Measure |
Usual Care
n=15 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=15 Participants
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.
|
|---|---|---|
|
Dietary Fiber Intake
Total Dietary Fiber Intake at 6mo postpartum
|
19.48 g/day
Standard Deviation 6.72
|
26.94 g/day
Standard Deviation 7.58
|
|
Dietary Fiber Intake
Total Dietary Fiber Intake at 12mo postpartum
|
17.87 g/day
Standard Deviation 6.31
|
23.80 g/day
Standard Deviation 7.13
|
SECONDARY outcome
Timeframe: 2-months through 12-months postpartumPopulation: Between the 2mo and 12mo timepoint, one participant withdrew from the study
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).
Outcome measures
| Measure |
Usual Care
n=15 Participants
Women in the usual care group, will received standard care from the obstetrician.
|
High Fiber
n=15 Participants
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.
|
|---|---|---|
|
Dietary Quality
Alternative Healthy Eating Index (AHEI) Total Score at 6mo postpartum
|
49.47 AHEI score
Standard Deviation 11.72
|
66.05 AHEI score
Standard Deviation 13.69
|
|
Dietary Quality
Alternative Healthy Eating Index (AHEI) Total Score at 12mo postpartum
|
48.66 AHEI score
Standard Deviation 12.14
|
61.59 AHEI score
Standard Deviation 10.11
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Fiber
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place