Helping Moms to be Healthy After Baby

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Weight Loss; Obesity; Diet Modification

Treatments: Behavioral: Lifestyle group participants; Behavioral: Observation Group participants

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03257657

UL1TR002535 (U.S. NIH Grant/Contract)

16-1932

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Observational Group

Experimental 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.

Treatment:

Behavioral: Observation Group participants

Lifestyle Group

Experimental 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.

Treatment:

Behavioral: Lifestyle group participants