Preventing Excessive Gestational Weight Gain in Obese Women

• Sponsor: California Polytechnic State University-San Luis Obispo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01545934
• Collaborator: Brown University (Other)
• Enrollment: 264
• Locations: 2
• Arms: 2
• Actual Duration (Months): 91
• Patients Per Site: 132
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Lifestyle intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 264 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Preventing Excessive Gestational Weight Gain in Obese Women
• Actual Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Care
Experimental: Lifestyle intervention	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Weight Gain Per Week of Observation [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.

Secondary Outcome Measures

1. Offspring Weight Gain [1 week, 6 months, 12 months]

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

2. Kcals/Day [13 weeks gestation, 34 weeks gestation]

   Changes in maternal calorie intake (Kcal/day)

3. Changes in Offspring Dietary Intake [1 week, 6 months, 12 months]

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

4. Changes in Maternal Glucose [13 weeks gestation, 34 weeks gestation]

   Fasting glucose

5. Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. [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.

6. Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Over 18 years old

• < 16 weeks gestation

• BMI >= 25

• Willing to consent

Exclusion Criteria:

• Pregnant with Twins

• Untreated medical or psychological problem

• Inability to be physically active

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Polytechnic State University	San Luis Obispo	California	United States	93401
2	Miriam Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• California Polytechnic State University-San Luis Obispo
• Brown University

Investigators

• Principal Investigator: Suzanne Phelan, PhD, Cal Poly

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzanne Phelan, Principle Investigator, California Polytechnic State University-San Luis Obispo
• ClinicalTrials.gov Identifier: NCT01545934
• Other Study ID Numbers: U01 HL114377A
• First Posted: Mar 7, 2012
• Last Update Posted: Aug 2, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Suzanne Phelan, Principle Investigator, California Polytechnic State University-San Luis Obispo: Overweight; Obese; Pregnancy; Weight Gain
• Additional relevant MeSH terms: Weight Gain; Gestational Weight Gain

Study Results

Participant Flow

Arm/Group Title	Standard Care	Lifestyle Intervention
Arm/Group Description	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: 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.
Period Title: Overall Study
STARTED	132	132
COMPLETED	127	129
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Standard Care	Lifestyle Intervention	Total
Arm/Group Description	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: 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 of all reporting groups
Overall Participants	128	129	257
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.7 (5.5)	30.7 (5.3)	30.3 (5.4)
Sex: Female, Male (Count of Participants)
Female	128 100%	129 100%	257 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	54 42.2%	53 41.1%	107 41.6%
Not Hispanic or Latino	74 57.8%	76 58.9%	150 58.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	128 100%	129 100%	257 100%

Outcome Measures

1. Primary Outcome

Title	Weight Gain Per Week of Observation
Description	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.
Time Frame	13 weeks gestation, 35 weeks gestation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Lifestyle Intervention
Arm/Group Description	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: 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.
Measure Participants	127	129
Least Squares Mean (Standard Deviation) [kg/wk]	0.39 (0.23)	0.33 (0.25)

2. Secondary Outcome

Title	Offspring Weight Gain
Description	Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.
Time Frame	1 week, 6 months, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Kcals/Day
Description	Changes in maternal calorie intake (Kcal/day)
Time Frame	13 weeks gestation, 34 weeks gestation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Lifestyle Intervention
Arm/Group Description	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: 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.
Measure Participants	128	129
13 weeks	1777	1743
34 weeks	1785	1673

4. Secondary Outcome

Title	Changes in Offspring Dietary Intake
Description	Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
Time Frame	1 week, 6 months, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Changes in Maternal Glucose
Description	Fasting glucose
Time Frame	13 weeks gestation, 34 weeks gestation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Lifestyle Intervention
Arm/Group Description	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: 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.
Measure Participants	127	129
13 weeks	84	87
34 weeks	85	83

6. Secondary Outcome

Title	Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.
Description	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.
Time Frame	13 weeks, 40 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Lifestyle Intervention
Arm/Group Description	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: 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.
Measure Participants	127	129
Count of Participants [Participants]	69 53.9%	53 41.1%

7. Secondary Outcome

Title	Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group
Description	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.
Time Frame	48-56 weeks post delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Lifestyle Intervention
Arm/Group Description	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: 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.
Measure Participants	128	129
Count of Participants [Participants]	38 29.7%	41 31.8%

Adverse Events

Time Frame	35 weeks gestation
Adverse Event Reporting Description	Preterm delivery (< 36 weeks)
Arm/Group Title	Standard Care		Lifestyle Intervention
Arm/Group Description	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: 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.
All Cause Mortality
	Standard Care		Lifestyle Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Care		Lifestyle Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/128 (0%)		0/129 (0%)
Other (Not Including Serious) Adverse Events
	Standard Care		Lifestyle Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/128 (3.9%)		4/129 (3.1%)
General disorders
Preterm Delivery	5/128 (3.9%)	5	4/129 (3.1%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.