Trial Outcomes & Findings for Preventing Excessive Gestational Weight Gain in Obese Women (NCT NCT01545934)

NCT ID: NCT01545934

Last Updated: 2021-08-02

Results Overview

Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 264 participants
• Primary outcome timeframe: 13 weeks gestation, 35 weeks gestation
• Results posted on: 2021-08-02

Participant Flow

Participant milestones

Measure	Standard Care Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
Overall Study STARTED	132	132
Overall Study COMPLETED	127	129
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	Standard Care Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
Overall Study Withdrawal by Subject	4	3
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Preventing Excessive Gestational Weight Gain in Obese Women

Baseline characteristics by cohort

Measure	Standard Care n=128 Participants Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention n=129 Participants Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.	Total n=257 Participants Total of all reporting groups
Age, Continuous	29.7 years STANDARD_DEVIATION 5.5 • n=5 Participants	30.7 years STANDARD_DEVIATION 5.3 • n=7 Participants	30.3 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	129 Participants n=7 Participants	257 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=5 Participants	53 Participants n=7 Participants	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	76 Participants n=7 Participants	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	128 participants n=5 Participants	129 participants n=7 Participants	257 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks gestation, 35 weeks gestation

Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.

Outcome measures

Measure	Standard Care n=127 Participants Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention n=129 Participants Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
Weight Gain Per Week of Observation	0.39 kg/wk Standard Deviation 0.23	0.33 kg/wk Standard Deviation 0.25

SECONDARY outcome

Timeframe: 1 week, 6 months, 12 months

Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks gestation, 34 weeks gestation

Changes in maternal calorie intake (Kcal/day)

Outcome measures

Measure	Standard Care n=128 Participants Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention n=129 Participants Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
Kcals/Day 13 weeks	1777 kcals/day Interval 1681.0 to 1873.0	1743 kcals/day Interval 1649.0 to 1837.0
Kcals/Day 34 weeks	1785 kcals/day Interval 1685.0 to 1888.0	1673 kcals/day Interval 1570.0 to 1776.0

SECONDARY outcome

Timeframe: 1 week, 6 months, 12 months

Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks gestation, 34 weeks gestation

Fasting glucose

Outcome measures

Measure	Standard Care n=127 Participants Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention n=129 Participants Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
Changes in Maternal Glucose 13 weeks	84 mg/dL Interval 84.0 to 88.0	87 mg/dL Interval 85.0 to 88.0
Changes in Maternal Glucose 34 weeks	85 mg/dL Interval 83.0 to 86.0	83 mg/dL Interval 81.0 to 84.0

SECONDARY outcome

Timeframe: 13 weeks, 40 weeks

Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding 2009 IOM guidelines if the difference is > 11.5 kg gain for women with prepregnancy overweight or >9 kg for women with prepregnancy obesity.

Outcome measures

Measure	Standard Care n=127 Participants Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention n=129 Participants Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.	69 Participants	53 Participants

SECONDARY outcome

Timeframe: 48-56 weeks post delivery

Weight measured at 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight.

Outcome measures

Measure	Standard Care n=128 Participants Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention n=129 Participants Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group	38 Participants	41 Participants

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Lifestyle Intervention

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard Care n=128 participants at risk Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC)	Lifestyle Intervention n=129 participants at risk Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
General disorders Preterm Delivery	3.9% 5/128 • Number of events 5 • 35 weeks gestation Preterm delivery (\< 36 weeks)	3.1% 4/129 • Number of events 4 • 35 weeks gestation Preterm delivery (\< 36 weeks)

Additional Information

Suzanne Phelan

Cal Poly

Phone: 805-756-2087

Email: sphelan@calpoly.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place