Helping Moms to be Healthy After Baby

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03257657

Enrollment

Registered

2017-08-22

Start date

2017-07-31

Completion date

2018-02-22

Last updated

2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Modification, Obesity, Weight Loss

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.

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.

Interventions

BEHAVIORALObservation 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.

BEHAVIORALLifestyle group participants

Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

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.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
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.
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.
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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.	22
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. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.	19
Total	41

Withdrawals & dropouts

Period	Reason	FG001
Overall Study	Lost to Follow-up	3
Overall Study	Noted not eligible right after enrolled	1
Overall Study	Withdrawn	1

Baseline characteristics

Characteristic	Observational Group	Lifestyle Group	Total
Age, Continuous	31.2 years STANDARD_DEVIATION 6.6	30.5 years STANDARD_DEVIATION 5	30.9 years STANDARD_DEVIATION 5.8
Race/Ethnicity, Customized African American, non-Hispanic	1 Participants	2 Participants	3 Participants
Race/Ethnicity, Customized Hispanic	20 Participants	17 Participants	37 Participants
Race/Ethnicity, Customized White, non-Hispanic	1 Participants	0 Participants	1 Participants
Sex: Female, Male Female	22 Participants	19 Participants	41 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	0 / 22	0 / 19
other Total, other adverse events	0 / 22	0 / 19
serious Total, serious adverse events	0 / 22	0 / 19

Outcome results

Primary

Acceptability of a Weight Loss Intervention

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

Population: 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	Measure	Value (COUNT_OF_PARTICIPANTS)
Observational Group	Acceptability of a Weight Loss Intervention	14 Participants

Primary

Attrition Rate of Subjects Enrolled in the Study

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

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Observational Group	Attrition Rate of Subjects Enrolled in the Study	0 Participants
Lifestyle Group	Attrition Rate of Subjects Enrolled in the Study	4 Participants

Primary

Evaluation of the Use of Phone Coaching

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

Time frame: 12 weeks

Arm	Measure	Value (NUMBER)
Observational Group	Evaluation of the Use of Phone Coaching	1 Number of phone coaching sessions

Primary

Feasibility of Recruitment

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

Population: 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	Measure	Value (NUMBER)
Observational Group	Feasibility of Recruitment	22 participants
Lifestyle Group	Feasibility of Recruitment	19 participants

Primary

Visit Attendance

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

Population: 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	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Observational Group	Visit Attendance	Attended all 4 visits (Baseline, 4 week visit, 8	7 Participants
Observational Group	Visit Attendance	Attended 3 of 4 visits (Baseline, 4 or 8 week visi	5 Participants
Observational Group	Visit Attendance	Attended 2 of 4 visits (baseline and 12 week visi	3 Participants
Observational Group	Visit Attendance	Attended 0 intervention visits	3 Participants

Secondary

Change in Weight Between Visits

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

Arm	Measure	Value (MEAN)	Dispersion
Observational Group	Change in Weight Between Visits	-0.8 pounds	Standard Deviation 6.4
Lifestyle Group	Change in Weight Between Visits	-4.7 pounds	Standard Deviation 7.5

p-value: 0.1t-test, 2 sided

Secondary

Changes in Diet and Physical Activity Self-efficacy

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.