Obesity
Conditions
Keywords
Overweight, Obese, Pregnancy, Weight Gain
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.
Interventions
BEHAVIORALLifestyle 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.
Sponsors
Brown University
California Polytechnic State University-San Luis Obispo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Kcals/Day | 13 weeks gestation, 34 weeks gestation | Changes in maternal calorie intake (Kcal/day) |
| 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). |
| 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. |
| 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. |
| 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. |
| Changes in Maternal Glucose | 13 weeks gestation, 34 weeks gestation | Fasting glucose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 128 |
| 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. | 129 |
| Total | 257 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Standard Care | Lifestyle Intervention | Total |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 5.5 | 30.7 years STANDARD_DEVIATION 5.3 | 30.3 years STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 53 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 76 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 128 participants | 129 participants | 257 participants |
| Sex: Female, Male Female | 128 Participants | 129 Participants | 257 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 | — / — | — / — |
| other Total, other adverse events | 5 / 128 | 4 / 129 |
| serious Total, serious adverse events | 0 / 128 | 0 / 129 |
Outcome results
Primary
Weight Gain Per Week of Observation
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Weight Gain Per Week of Observation | 0.39 kg/wk | Standard Deviation 0.23 |
| Lifestyle Intervention | Weight Gain Per Week of Observation | 0.33 kg/wk | Standard Deviation 0.25 |
Secondary
Changes in Maternal Glucose
Fasting glucose
Time frame: 13 weeks gestation, 34 weeks gestation
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Care | Changes in Maternal Glucose | 13 weeks | 84 mg/dL |
| Standard Care | Changes in Maternal Glucose | 34 weeks | 85 mg/dL |
| Lifestyle Intervention | Changes in Maternal Glucose | 13 weeks | 87 mg/dL |
| Lifestyle Intervention | Changes in Maternal Glucose | 34 weeks | 83 mg/dL |
Secondary
Changes in Offspring Dietary Intake
Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
Time frame: 1 week, 6 months, 12 months
Secondary
Kcals/Day
Changes in maternal calorie intake (Kcal/day)
Time frame: 13 weeks gestation, 34 weeks gestation
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Care | Kcals/Day | 13 weeks | 1777 kcals/day |
| Standard Care | Kcals/Day | 34 weeks | 1785 kcals/day |
| Lifestyle Intervention | Kcals/Day | 13 weeks | 1743 kcals/day |
| Lifestyle Intervention | Kcals/Day | 34 weeks | 1673 kcals/day |
Secondary
Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group | 38 Participants |
| Lifestyle Intervention | Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group | 41 Participants |
Secondary
Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. | 69 Participants |
| Lifestyle Intervention | Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. | 53 Participants |
Secondary
Offspring Weight Gain
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