Weight Gain During Pregnancy
Conditions
Keywords
Pregnancy, Gestational weight gain
Brief summary
The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.
Detailed description
The study will last 22 months, from screening until study completion. The entire study will include 3 screening visits, receipt of weight management advice, second trimester testing, third trimester testing and three follow up visits during the first year after the baby is born. Participants will randomly be assigned to 1 of 3 programs to help manage their weight during pregnancy: 1. Physician Directed group 2. SmartMoms-Clinic group 3. SmartMoms-Phone group
Interventions
BEHAVIORALSmartMoms
This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Are pregnant. * Are between 18 and 40 years old. * Have a BMI (a number calculated from your height and weight) equal to or above 25kg/m2. * Establish prenatal care before 12 weeks of your pregnancy. * Can read, speak and understand English.
Exclusion criteria
* Do not plan to deliver your baby at Woman's Hospital, Baton Rouge, LA * Are pregnant with more than one infant. * Have habitually smoked during the last 6 months. * Currently abuse or have abused illegal or prescription drugs in the last 6 months. * Consume more than 2 alcoholic drinks per week. * Are unwilling to avoid pregnancy for 12 months following delivery. * Are unwilling to enroll your baby in the 12 month follow-up testing planned in this study. * Are planning to move out of the area within the next 2 years or plan to be out of the study area for more than 1 month in the next year. * Are unwilling to be assigned at random to any of the intervention groups. * Are planning to terminate your pregnancy. * Are planning to give your baby up for adoption. * Are pregnant with a baby who has a known fetal anomaly. * Have a reason that exercising is unsafe (determined by your physician or study staff). * Have had or plan to have bariatric surgery within 1 year of your expected delivery. * Currently have or have a history of the following: * 3 or more first trimester miscarriages * High blood pressure * Type 1 diabetes * Diagnosis of pregnancy related diabetes during screening * HIV or AIDS * Psychotic disorder, major depressive episode, bipolar disorder or eating disorder * Any other pregnancy, blood, heart, lung, hormone, or digestive problem that your doctor considers unsafe for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Women Who Have Excess Gestational Weight Gain | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) | Count of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Gestational Weight Gain | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) | — |
| Gestational Weight Gain Per Week | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) | per week is included to adjust for the different length of time between weight measurements |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SmartMoms-Clinic If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits. | 18 |
| SmartMoms-Phone If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits. | 19 |
| Physician Directed If picked for this group, you will receive weight management advice from your physician's office. | 17 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Miscarriage/Pregnancy loss | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Total | SmartMoms-Clinic | SmartMoms-Phone | Physician Directed |
|---|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 4.6 | 29.2 years STANDARD_DEVIATION 4.8 | 29.0 years STANDARD_DEVIATION 4.2 | 29.5 years STANDARD_DEVIATION 5.1 |
| Education College degree | 22 Participants | 7 Participants | 11 Participants | 4 Participants |
| Education High school diploma/GED/1-3 years of college | 18 Participants | 5 Participants | 6 Participants | 7 Participants |
| Education Postgraduate work | 13 Participants | 5 Participants | 2 Participants | 6 Participants |
| Education Some high school | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Family income per year ≥$100,000 | 14 Participants | 2 Participants | 7 Participants | 5 Participants |
| Family income per year $40,000-$99,999 | 17 Participants | 7 Participants | 5 Participants | 5 Participants |
| Family income per year <$5000-$39,999 | 23 Participants | 9 Participants | 7 Participants | 7 Participants |
| Parity | 0.8 viable pregnancies STANDARD_DEVIATION 0.8 | 0.7 viable pregnancies STANDARD_DEVIATION 0.8 | 0.9 viable pregnancies STANDARD_DEVIATION 1.1 | 0.6 viable pregnancies STANDARD_DEVIATION 0.5 |
| Pregravid BMI Obese (30.0-40.0 kg/m2) | 29 Participants | 10 Participants | 11 Participants | 8 Participants |
| Pregravid BMI Overweight (25.0-29.9 kg/m2) | 25 Participants | 8 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 5 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 11 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Female | 54 Participants | 18 Participants | 19 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 13 / 18 | 15 / 19 | 12 / 17 |
| serious Total, serious adverse events | 2 / 18 | 1 / 19 | 5 / 17 |
Outcome results
Primary
Count of Women Who Have Excess Gestational Weight Gain
Count of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines
Time frame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SmartMoms-Clinic | Count of Women Who Have Excess Gestational Weight Gain | 10 Participants |
| SmartMoms-Phone | Count of Women Who Have Excess Gestational Weight Gain | 11 Participants |
| Physician Directed | Count of Women Who Have Excess Gestational Weight Gain | 11 Participants |
Secondary
Gestational Weight Gain Per Week
per week is included to adjust for the different length of time between weight measurements
Time frame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SmartMoms-Clinic | Gestational Weight Gain Per Week | 0.31 kilograms per week | Standard Error 0.05 |
| SmartMoms-Phone | Gestational Weight Gain Per Week | 0.39 kilograms per week | Standard Error 0.05 |
| Physician Directed | Gestational Weight Gain Per Week | 0.49 kilograms per week | Standard Error 0.06 |
Secondary
Total Gestational Weight Gain
Time frame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SmartMoms-Clinic | Total Gestational Weight Gain | 8.0 kilograms | Standard Error 1.3 |
| SmartMoms-Phone | Total Gestational Weight Gain | 10.0 kilograms | Standard Error 1.2 |
| Physician Directed | Total Gestational Weight Gain | 12.8 kilograms | Standard Error 1.5 |
Post Hoc
Intervention Cost for Clinic
Clinic costs included interventionist time for training, session preparation, participant contacts, routine staff meetings, and scale and pedometer cost. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention. The US dollar cost was standard across each participant in each group so there is $0 standard deviation.
Time frame: Approximately 6 months (from 1st trimester until delivery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SmartMoms-Clinic | Intervention Cost for Clinic | 419 US dollars | Standard Deviation 0 |
| SmartMoms-Phone | Intervention Cost for Clinic | 215 US dollars | Standard Deviation 0 |
Post Hoc
Intervention Cost for Participant
Costs incurred for travel to and from treatment sessions and time spent with the counselor while accounting for session attendance and intervention adherence. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention.
Time frame: Approximately 6 months (from 1st trimester until delivery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SmartMoms-Clinic | Intervention Cost for Participant | 347 US dollars | Standard Deviation 40 |
| SmartMoms-Phone | Intervention Cost for Participant | 97 US dollars | Standard Deviation 6 |
Post Hoc
Percentage of Days With Intervention Adherence
Adherence to the SmartMoms intervention was defined as the percentage of days participants weighed and recorded step counts in comparison to the expected number of days. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention.
Time frame: Approximately 6 months (from 1st trimester until delivery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SmartMoms-Clinic | Percentage of Days With Intervention Adherence | 60.8 percentage of days | Standard Deviation 6.4 |
| SmartMoms-Phone | Percentage of Days With Intervention Adherence | 76.5 percentage of days | Standard Deviation 4.5 |