Helping Moms to be Healthy After Baby

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT03257657
• Collaborator: Colorado Clinical & Translational Sciences Institute (Other), National Center for Advancing Translational Science (NCATS) (NIH)
• Enrollment: 42
• Locations: 2
• Arms: 2
• Actual Duration (Months): 6.8
• Patients Per Site: 21
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below:

Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women.

Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Diet Modification; Obesity	Behavioral: Observation Group participants; Behavioral: Lifestyle group participants	N/A

Detailed Description

Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women.

Obesity science supports that weight loss interventions should be multi-component with regular points of contact. Building upon this, we have designed a multi-component intervention that considers the demands on women in the postpartum period and utilizes technology for both provider decision support and for virtual contact with participants. The intervention will address diet, physical activity, and social support through the use of in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and Facebook.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Helping Moms to be Healthy After Baby
• Actual Study Start Date: Jul 31, 2017
• Actual Primary Completion Date: Feb 22, 2018
• Actual Study Completion Date: Feb 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Observational Group Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.	Behavioral: Observation Group participants; Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.
Experimental: Lifestyle Group Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.	Behavioral: Lifestyle group participants; Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Feasibility of Recruitment [Once the final participant is recruited]

   The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment

2. Attrition Rate of Subjects Enrolled in the Study [Once the final participant completes the 12 week visit]

   The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.

3. Visit Attendance [Baseline through Week 12, reported at Week 12]

   The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported

4. Acceptability of a Weight Loss Intervention [12 weeks]

   To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.

5. Evaluation of the Use of Phone Coaching [12 weeks]

   Investigators will count the total number of times any participant used phone coaching.

Secondary Outcome Measures

1. Change in Weight Between Visits [Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks]

   To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.

2. Changes in Diet: Intakes Measured in Grams [Baseline and 12 weeks]

   To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.

3. Changes in Physical Activity [Baseline and 12 weeks]

   To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.

4. Changes in Diet and Physical Activity Self-efficacy [Baseline and 12 weeks]

   To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey. Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.

5. Changes in Motivations to Eat [Baseline and 12 weeks]

   To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire. Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.

6. Changes in Readiness to Change [Baseline and 12 weeks]

   Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change

7. Changes in Diet: Intakes Measured in Cups [Baseline and 12 weeks]

   To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.

8. Changes in Diet: kCal Intake [Baseline and 12 weeks]

   To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult woman (≥18 and <50 years old).

• Enrolled in WIC or with an infant enrolled in WIC.

• 3-12 months postpartum.

• A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior to pregnancy).

• Postpartum body mass index between 25 and 50 kg/m2.

• English- and/or Spanish-speaking.

• Owns a mobile phone with texting functionality in order to receive texts during the trial.

Exclusion Criteria:

• Health conditions impacting weight or ability to participate in a weight loss trial.

• Pregnancy or planned pregnancy in next 5 months.

• Any health problems or undergoing any treatments that might interfere with what participant eats or her ability to exercise.

• Medical provider recommendation to avoid exercise.

• Plans to be in a different geographic area within the next 5 months.

• Plans to stop coming to Aurora WIC in the next 5 months.

• Unable to give informed consent.

• Not able to read and understand English or Spanish at an 8th grade level.

• Not willing to create a Facebook account if they do not already have one.

• Asked to follow-up in < 3 months at most recent WIC visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aurora WIC Office	Aurora	Colorado	United States	80011
2	University of Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• Colorado Clinical & Translational Sciences Institute
• National Center for Advancing Translational Science (NCATS)

Investigators

• Principal Investigator: Darcy A Thompson, MD, MPH, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 8, 2017

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03257657
• Other Study ID Numbers: 16-1932; UL1TR002535
• First Posted: Aug 22, 2017
• Last Update Posted: Mar 20, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Weight Loss

Study Results

Participant Flow

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Period Title: Overall Study
STARTED	22	20
COMPLETED	22	15
NOT COMPLETED	0	5

Baseline Characteristics

Arm/Group Title	Observational Group	Lifestyle Group	Total
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.	Total of all reporting groups
Overall Participants	22	19	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.2 (6.6)	30.5 (5.0)	30.9 (5.8)
Sex: Female, Male (Count of Participants)
Female	22 100%	19 100%	41 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	20 90.9%	17 89.5%	37 90.2%
African American, non-Hispanic	1 4.5%	2 10.5%	3 7.3%
White, non-Hispanic	1 4.5%	0 0%	1 2.4%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Recruitment
Description	The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment
Time Frame	Once the final participant is recruited

Outcome Measure Data

Analysis Population Description

One participant was consented but determined before receiving any interventions that they did not meet all eligibility criteria. This participant is excluded from the lifestyle group.

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	19
Number [participants]	22 100%	19 100%

2. Primary Outcome

Title	Attrition Rate of Subjects Enrolled in the Study
Description	The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.
Time Frame	Once the final participant completes the 12 week visit

Outcome Measure Data

Analysis Population Description

The 1 participant originally enrolled, but removed right after enrollment because was determined not eligible is not included in the Lifestyle group count.

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	19
Count of Participants [Participants]	0 0%	4 21.1%

3. Primary Outcome

Title	Visit Attendance
Description	The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported
Time Frame	Baseline through Week 12, reported at Week 12

Outcome Measure Data

Analysis Population Description

2 participants are excluded from analysis: Participant who was withdrawn was not included in analysis. Participant identified as not eligible right after enrollment is not included either.

Arm/Group Title	Lifestyle Group
Arm/Group Description	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	18
Attended all 4 visits (Baseline, 4 week visit, 8	7 31.8%
Attended 3 of 4 visits (Baseline, 4 or 8 week visi	5 22.7%
Attended 2 of 4 visits (baseline and 12 week visi	3 13.6%
Attended 0 intervention visits	3 13.6%

4. Primary Outcome

Title	Acceptability of a Weight Loss Intervention
Description	To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Data was not available for analysis for one participant. This participant was not analyzed. The three participants lost to follow-up before the baseline visit were not available for interview and are excluded.

Arm/Group Title	Lifestyle Group
Arm/Group Description	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	14
Count of Participants [Participants]	14 63.6%

5. Primary Outcome

Title	Evaluation of the Use of Phone Coaching
Description	Investigators will count the total number of times any participant used phone coaching.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Group
Arm/Group Description	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	19
Number [Number of phone coaching sessions]	1

6. Secondary Outcome

Title	Change in Weight Between Visits
Description	To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.
Time Frame	Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	15
Mean (Standard Deviation) [pounds]	-0.8 (6.4)	-4.7 (7.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Observational Group, Lifestyle Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Changes in Diet: Intakes Measured in Grams
Description	To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Data missing for one Lifestyle Group participant at the 12 week point

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	14
Saturated fat (g)	-3.7 (8.1)	-4.1 (5.7)
Trans fat (g)	0.2 (3.5)	-1.2 (2.7)
Total sugars (g)	-35.1 (50.4)	-25.2 (34)
Added sugars (g)	-25.7 (39.5)	-23.3 (33.6)
protein (g)	-10.2 (22.2)	-6.3 (25.5)
total fat (g)	-9.9 (24.5)	-9.4 (16.4)
carbohydrates (g)	-40.9 (79.8)	-46.7 (48.8)
fiber (g)	0.1 (4.8)	-0.4 (3.1)

8. Secondary Outcome

Title	Changes in Physical Activity
Description	To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	15
Mean (Standard Deviation) [MET-h/week]	-45.5 (176)	38.6 (126)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Observational Group, Lifestyle Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	t-test, 2 sided
	Comments

9. Secondary Outcome

Title	Changes in Diet and Physical Activity Self-efficacy
Description	To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey. Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	14
Physical activity: Sticking to it	-0.5 (0.9)	0.4 (1.0)
Physical activity: making time for exercise	-0.3 (1.0)	0.0 (0.8)
Diet	3.3 (3.1)	-0.1 (7.2)

10. Secondary Outcome

Title	Changes in Motivations to Eat
Description	To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire. Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	14
Mean (Standard Deviation) [units on a scale]	-3.3 (9.6)	5.9 (12.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Observational Group, Lifestyle Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Changes in Readiness to Change
Description	Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	14
Losing weight	0	1.0
Healthy eating	0	1.0
Physical activity	0	1.0

12. Secondary Outcome

Title	Changes in Diet: Intakes Measured in Cups
Description	To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Data missing for one Lifestyle Group participant at the 12 week point

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	14
Fruit and fruit juice (cups)	-0.2 (1.5)	0 (1.4)
vegetable intake (cups)	-0.1 (0.9)	0.3 (0.9)

13. Secondary Outcome

Title	Changes in Diet: kCal Intake
Description	To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Data missing for one Lifestyle Group participant at the 12 week point

Arm/Group Title	Observational Group	Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.	Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Measure Participants	22	14
Mean (Standard Deviation) [kcal]	-294 (531.7)	-297 (374.7)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Observational Group		Lifestyle Group
Arm/Group Description	Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.		Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
All Cause Mortality
	Observational Group		Lifestyle Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/19 (0%)
Serious Adverse Events
	Observational Group		Lifestyle Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Observational Group		Lifestyle Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/19 (0%)

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.