Overweight and Obesity, Pregnancy
Conditions
Keywords
diabetes prevention program, breastfeeding, prediabetes
Brief summary
The purpose of this study is to learn about the impact of the Diabetes Prevention Program (DPP) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood sugars and blood pressure, and increase duration of breastfeeding their infant.
Detailed description
This pilot randomized controlled trial seeks to determine the feasibility and efficacy of a combined breastfeeding, DPP-based program in a cohort of overweight/obese women to be followed during pregnancy through 6 months postpartum. The pilot trial will have three study arms: DPP + breastfeeding (Tx1), DPP only (Tx2), and usual care (Tx3). Specific aims are: 1) To test the efficacy of Tx1 to improve 6-month postpartum weight loss among women with a BMI \>/= 25. 2) To test the efficacy of Tx1 to improve 6-month postpartum mean blood glucose (HbA1c) and mean arterial blood pressure among women with a BMI \>/= 25. 3) To test the efficacy of Tx1 to increase any breastfeeding through 6 months postpartum among women with a BMI \>/= 25.
Interventions
BEHAVIORALDiabetes Prevention Program
Phase 1 (core curriculum) of the Diabetes Prevention Program consists of 16 sessions and will take place during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions to which participants will have access. A research coordinator will follow up with each study participant by phone once weekly. If participants do not make adequate progress, the coordinator will assess how much extra time the participant will need to complete each session and will work with the participant if needed. Phase 2 (post-core curriculum) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum. The same session completion format and procedure for inadequate progress will be followed as during pregnancy.
BEHAVIORALBreastfeeding Education
Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
BEHAVIORALUsual Care
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Sponsors
Ascension Via Christi Hospitals Wichita, Inc.
Kearny County Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant, 1st trimester or early 2nd trimester * Interested in breastfeeding * BMI \>/= 25 and \<35 * Able to read and understand English * Able to learn and use Facebook * Able to learn and use Skype, FaceTime or Zoom for virtual meetings * Must have a cell phone
Exclusion criteria
* Pregnancy complications that require emergency care * Thyroid disease * Multiple gestation * Substance abuse within last 3 years * ART (Assisted Reproductive Technology) pregnancy * Current smoker * Prior bariatric surgery * In weight-loss program within 3 months of conception * BMI \>/= 35 * Unable to attend intervention / follow-up visits * Unwilling to self-monitor data collection * Unable to complete intervention * Presence of any condition that limits walking * Presence of any condition that limits following diet recommendations * Pregnancies complicated with fetuses diagnosed with lethal malformations / conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Breastfeeding | At delivery through 6 months postpartum | The study team will measure duration of breastfeeding from delivery through 6 months postpartum. |
| Change in Weight | At baseline and at delivery through 6 months postpartum | The study team will measure maternal weight at baseline, at delivery, and weekly during the postpartum period to allow for meaningful comparisons of weight change among study arms. |
| Change in HbA1c | At baseline and at 6 months postpartum | The study team will measure mean blood glucose at baseline and at 6 months postpartum. |
| Change in Arterial Blood Pressure | At baseline, at delivery, and at 6 months postpartum | The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey) | At baseline and at 6 months postpartum | To assess levels of self-efficacy. Survey consists of 14 items. All items are preceded by the phrase I can always and are anchored with a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. All items are presented positively, and scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy. |
| Kaiser Physical Activity Survey (KPAS, Weighted Total) | At baseline and at 6 months postpartum | To assess multiple domains of physical activity and total physical activity before and after pregnancy. Survey consists of 38 items; 4 domains: household and family care activities, occupational activities, active living habits, participation in sports/exercise. Activity indices were created for each domain of activity by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5 (scores ranged from 1 for never or none to 5 for always or more than once a week in each physical activity domain). Higher scores indicate greater overall activity levels. Total activity index is calculated as the sum of all four indices: Total activity = (household/caregiving index\*0.25 + occupational index\*0.25 + active living index\*0.25 + sports/exercise index\*0.25) \* 4. The total activity score has a potential range of 4 - 20 with a mean of 10.42 (SD=2.00). A higher total activity score indicates a greater activity level. |
| Fruit & Vegetable Intake Screener (EATS) | At baseline and at 6 months postpartum | To assess intake of fruits and vegetables before and after pregnancy. Survey consists of 10 items; with portion-size questions. Each question has two parts, asking over the last month how often a particular item was consumed (i.e.: never, 1-3x/mo, 1-2x/wk, etc.) and how much was usually consumed (i.e.: \<3/4cup, 3/4 to 1 1/4 cup, \>2 cups, etc.). Frequency is scored from 0.0-5.0, with 0 meaning never, and 5.0 meaning 5 or more servings per day. |
| Edinburgh Postnatal Depression Scale (EPDS) | Postpartum | To assess levels of depression during the postpartum period. Survey consists of 10 items. Questions 1, 2, & 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3, 5--10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score is 30. A score of 10 or higher generally indicates a potential need for further assessment regarding possible depression, while scores above 12 or 13 may suggest a higher likelihood of depression requiring medical attention. Participants with a score of 10 or greater will be referred to their healthcare provider for follow up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital. | 9 |
| Intervention 2 (Tx2) - DPP Only + Usual Care Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital. | 14 |
| Intervention 3 (Tx3) - Usual Care Only Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital. | 12 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 | 1 |
Baseline characteristics
| Characteristic | Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Intervention 2 (Tx2) - DPP Only + Usual Care | Intervention 3 (Tx3) - Usual Care Only | Total |
|---|---|---|---|---|
| Age, Continuous | 27.9 years STANDARD_DEVIATION 7.4 | 27.1 years STANDARD_DEVIATION 5.2 | 27.6 years STANDARD_DEVIATION 5.4 | 27.5 years STANDARD_DEVIATION 5.7 |
| Currently have health insurance No | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Currently have health insurance Yes | 9 Participants | 14 Participants | 12 Participants | 35 Participants |
| Gross yearly total household income before taxes during the last 12 months before current pregnancy $10,000 to $24,999 | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Gross yearly total household income before taxes during the last 12 months before current pregnancy $25,000 to $49,999 | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Gross yearly total household income before taxes during the last 12 months before current pregnancy $50,000 to $74,999 | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Gross yearly total household income before taxes during the last 12 months before current pregnancy $75,000 or more | 1 Participants | 3 Participants | 4 Participants | 8 Participants |
| Gross yearly total household income before taxes during the last 12 months before current pregnancy $9,999 or less | 1 Participants | 4 Participants | 4 Participants | 9 Participants |
| Had a preterm delivery (baby was born before 37 weeks of pregnancy) No | 7 Participants | 13 Participants | 12 Participants | 32 Participants |
| Had a preterm delivery (baby was born before 37 weeks of pregnancy) Yes | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Highest Level of Education Completed Advanced degree (e.g. Masters, PhD, MD, JD) | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Highest Level of Education Completed Graduated from high school | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Highest Level of Education Completed Graduated with a bachelor's degree | 2 Participants | 3 Participants | 5 Participants | 10 Participants |
| Highest Level of Education Completed Some college or associate's degree | 3 Participants | 6 Participants | 6 Participants | 15 Participants |
| Highest Level of Education Completed Some high school | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Location Rural | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Location Urban | 9 Participants | 13 Participants | 10 Participants | 32 Participants |
| Number of live births (not including current pregnancy) 1 birth | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
| Number of live births (not including current pregnancy) 2 births | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Number of live births (not including current pregnancy) 3 births | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Number of live births (not including current pregnancy) 4 or more births | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Number of live births (not including current pregnancy) None | 2 Participants | 6 Participants | 6 Participants | 14 Participants |
| Number of stillbirths Did not answer | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Number of stillbirths None | 7 Participants | 12 Participants | 12 Participants | 31 Participants |
| Number of stillbirths One | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Pregnancy trimester at study entry 1st trimester | 4 Participants | 9 Participants | 8 Participants | 21 Participants |
| Pregnancy trimester at study entry 2nd trimester | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
| Pregnancy trimester at study entry 3rd trimester | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Hispanic | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Non-Hispanic Black | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Non-Hispanic White | 7 Participants | 8 Participants | 8 Participants | 23 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Other | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Reported immediate biological family member ever diagnosed with or treated for diabetes No | 4 Participants | 9 Participants | 8 Participants | 21 Participants |
| Reported immediate biological family member ever diagnosed with or treated for diabetes Yes | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 12 Participants | 35 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoking status Currently smoking | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoking status Not currently smoking | 9 Participants | 14 Participants | 12 Participants | 35 Participants |
| Type of diabetes (if diagnosed with pregestational diabetes) Not diagnosed with pregestational diabetes | 9 Participants | 12 Participants | 12 Participants | 33 Participants |
| Type of diabetes (if diagnosed with pregestational diabetes) Type 1 diabetes | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Type of diabetes (if diagnosed with pregestational diabetes) Type 2 diabetes | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| WIC participation during pregnancy No | 6 Participants | 11 Participants | 11 Participants | 28 Participants |
| WIC participation during pregnancy Yes | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 0 / 9 | 0 / 14 | 0 / 12 |
| serious Total, serious adverse events | 1 / 9 | 0 / 14 | 1 / 12 |
Outcome results
Primary
Change in Arterial Blood Pressure
The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum.
Time frame: At baseline, at delivery, and at 6 months postpartum
Population: We were unable to collect arterial blood pressure at certain time points for some participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Change in Arterial Blood Pressure | 6 months | 92.7 mmHg |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Change in Arterial Blood Pressure | Baseline | 85.0 mmHg |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Change in Arterial Blood Pressure | 6 months | 91.3 mmHg |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Change in Arterial Blood Pressure | Baseline | 90.7 mmHg |
| Intervention 3 (Tx3) - Usual Care Only | Change in Arterial Blood Pressure | 6 months | 90.8 mmHg |
| Intervention 3 (Tx3) - Usual Care Only | Change in Arterial Blood Pressure | Baseline | 89.7 mmHg |
Primary
Change in HbA1c
The study team will measure mean blood glucose at baseline and at 6 months postpartum.
Time frame: At baseline and at 6 months postpartum
Population: We were unable to collect HbA1c at certain time points for some participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Change in HbA1c | Baseline | 5.2 mmol/mol |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Change in HbA1c | 6 months | 5.3 mmol/mol |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Change in HbA1c | Baseline | 5.2 mmol/mol |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Change in HbA1c | 6 months | 5.4 mmol/mol |
| Intervention 3 (Tx3) - Usual Care Only | Change in HbA1c | Baseline | 5.0 mmol/mol |
| Intervention 3 (Tx3) - Usual Care Only | Change in HbA1c | 6 months | 5.1 mmol/mol |
Primary
Change in Weight
The study team will measure maternal weight at baseline, at delivery, and weekly during the postpartum period to allow for meaningful comparisons of weight change among study arms.
Time frame: At baseline and at delivery through 6 months postpartum
Population: We were unable to collect weight at certain time points for some participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Change in Weight | Delivery - 6 month postpartum | -5.6 kgs |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Change in Weight | Baseline - delivery (GWG) | 7.5 kgs |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Change in Weight | Baseline - 6 month postpartum | 4.1 kgs |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Change in Weight | Delivery - 6 month postpartum | -12.3 kgs |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Change in Weight | Baseline - delivery (GWG) | 13.4 kgs |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Change in Weight | Baseline - 6 month postpartum | 3.5 kgs |
| Intervention 3 (Tx3) - Usual Care Only | Change in Weight | Baseline - delivery (GWG) | 18.2 kgs |
| Intervention 3 (Tx3) - Usual Care Only | Change in Weight | Baseline - 6 month postpartum | 5.9 kgs |
| Intervention 3 (Tx3) - Usual Care Only | Change in Weight | Delivery - 6 month postpartum | -11.2 kgs |
Primary
Duration of Breastfeeding
The study team will measure duration of breastfeeding from delivery through 6 months postpartum.
Time frame: At delivery through 6 months postpartum
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Duration of Breastfeeding | 10 days | Still Breastfeeding | 4 Participants |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Duration of Breastfeeding | 10 days | No longer breastfeeding | 1 Participants |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Duration of Breastfeeding | 6 weeks | Still Breastfeeding | 3 Participants |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Duration of Breastfeeding | 6 weeks | No longer breastfeeding | 2 Participants |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Duration of Breastfeeding | 3 months | Still Breastfeeding | 3 Participants |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Duration of Breastfeeding | 3 months | No longer breastfeeding | 2 Participants |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Duration of Breastfeeding | 6 months | Still Breastfeeding | 2 Participants |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Duration of Breastfeeding | 6 months | No longer breastfeeding | 3 Participants |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Duration of Breastfeeding | 6 weeks | Still Breastfeeding | 4 Participants |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Duration of Breastfeeding | 6 months | Still Breastfeeding | 2 Participants |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Duration of Breastfeeding | 6 weeks | No longer breastfeeding | 7 Participants |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Duration of Breastfeeding | 3 months | Still Breastfeeding | 3 Participants |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Duration of Breastfeeding | 3 months | No longer breastfeeding | 8 Participants |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Duration of Breastfeeding | 10 days | Still Breastfeeding | 7 Participants |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Duration of Breastfeeding | 10 days | No longer breastfeeding | 4 Participants |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Duration of Breastfeeding | 6 months | No longer breastfeeding | 9 Participants |
| Intervention 3 (Tx3) - Usual Care Only | Duration of Breastfeeding | 6 weeks | Still Breastfeeding | 4 Participants |
| Intervention 3 (Tx3) - Usual Care Only | Duration of Breastfeeding | 10 days | No longer breastfeeding | 4 Participants |
| Intervention 3 (Tx3) - Usual Care Only | Duration of Breastfeeding | 10 days | Still Breastfeeding | 6 Participants |
| Intervention 3 (Tx3) - Usual Care Only | Duration of Breastfeeding | 6 weeks | No longer breastfeeding | 6 Participants |
| Intervention 3 (Tx3) - Usual Care Only | Duration of Breastfeeding | 6 months | Still Breastfeeding | 1 Participants |
| Intervention 3 (Tx3) - Usual Care Only | Duration of Breastfeeding | 3 months | No longer breastfeeding | 7 Participants |
| Intervention 3 (Tx3) - Usual Care Only | Duration of Breastfeeding | 3 months | Still Breastfeeding | 3 Participants |
| Intervention 3 (Tx3) - Usual Care Only | Duration of Breastfeeding | 6 months | No longer breastfeeding | 9 Participants |
Secondary
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)
To assess levels of self-efficacy. Survey consists of 14 items. All items are preceded by the phrase I can always and are anchored with a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. All items are presented positively, and scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
Time frame: At baseline and at 6 months postpartum
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey) | Baseline | 33.0 score on a scale |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey) | 6 months | 49.0 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey) | Baseline | 35.0 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey) | 6 months | 52.0 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey) | Baseline | 41.0 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey) | 6 months | 62.5 score on a scale |
Secondary
Edinburgh Postnatal Depression Scale (EPDS)
To assess levels of depression during the postpartum period. Survey consists of 10 items. Questions 1, 2, & 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3, 5--10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score is 30. A score of 10 or higher generally indicates a potential need for further assessment regarding possible depression, while scores above 12 or 13 may suggest a higher likelihood of depression requiring medical attention. Participants with a score of 10 or greater will be referred to their healthcare provider for follow up.
Time frame: Postpartum
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Edinburgh Postnatal Depression Scale (EPDS) | Week 12 | 9 score on a scale |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Edinburgh Postnatal Depression Scale (EPDS) | Month 6 | 7.5 score on a scale |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Edinburgh Postnatal Depression Scale (EPDS) | Week 6 | 7.5 score on a scale |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Edinburgh Postnatal Depression Scale (EPDS) | Week 3 | 7 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Edinburgh Postnatal Depression Scale (EPDS) | Week 3 | 6 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Edinburgh Postnatal Depression Scale (EPDS) | Week 6 | 6 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Edinburgh Postnatal Depression Scale (EPDS) | Month 6 | 4 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Edinburgh Postnatal Depression Scale (EPDS) | Week 12 | 6 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Edinburgh Postnatal Depression Scale (EPDS) | Month 6 | 3 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Edinburgh Postnatal Depression Scale (EPDS) | Week 3 | 5 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Edinburgh Postnatal Depression Scale (EPDS) | Week 6 | 4 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Edinburgh Postnatal Depression Scale (EPDS) | Week 12 | 3 score on a scale |
Secondary
Fruit & Vegetable Intake Screener (EATS)
To assess intake of fruits and vegetables before and after pregnancy. Survey consists of 10 items; with portion-size questions. Each question has two parts, asking over the last month how often a particular item was consumed (i.e.: never, 1-3x/mo, 1-2x/wk, etc.) and how much was usually consumed (i.e.: \<3/4cup, 3/4 to 1 1/4 cup, \>2 cups, etc.). Frequency is scored from 0.0-5.0, with 0 meaning never, and 5.0 meaning 5 or more servings per day.
Time frame: At baseline and at 6 months postpartum
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Fruit & Vegetable Intake Screener (EATS) | Baseline | 1.6 score on a scale |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Fruit & Vegetable Intake Screener (EATS) | 6 months | 1.9 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Fruit & Vegetable Intake Screener (EATS) | Baseline | 1.8 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Fruit & Vegetable Intake Screener (EATS) | 6 months | 1.8 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Fruit & Vegetable Intake Screener (EATS) | Baseline | 1.9 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Fruit & Vegetable Intake Screener (EATS) | 6 months | 3.1 score on a scale |
Secondary
Kaiser Physical Activity Survey (KPAS, Weighted Total)
To assess multiple domains of physical activity and total physical activity before and after pregnancy. Survey consists of 38 items; 4 domains: household and family care activities, occupational activities, active living habits, participation in sports/exercise. Activity indices were created for each domain of activity by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5 (scores ranged from 1 for never or none to 5 for always or more than once a week in each physical activity domain). Higher scores indicate greater overall activity levels. Total activity index is calculated as the sum of all four indices: Total activity = (household/caregiving index\*0.25 + occupational index\*0.25 + active living index\*0.25 + sports/exercise index\*0.25) \* 4. The total activity score has a potential range of 4 - 20 with a mean of 10.42 (SD=2.00). A higher total activity score indicates a greater activity level.
Time frame: At baseline and at 6 months postpartum
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Kaiser Physical Activity Survey (KPAS, Weighted Total) | Baseline | 12.1 score on a scale |
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Kaiser Physical Activity Survey (KPAS, Weighted Total) | 6 months | 12.4 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Kaiser Physical Activity Survey (KPAS, Weighted Total) | Baseline | 10.1 score on a scale |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Kaiser Physical Activity Survey (KPAS, Weighted Total) | 6 months | 12.2 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Kaiser Physical Activity Survey (KPAS, Weighted Total) | Baseline | 10.6 score on a scale |
| Intervention 3 (Tx3) - Usual Care Only | Kaiser Physical Activity Survey (KPAS, Weighted Total) | 6 months | 10.6 score on a scale |