Goals for Reaching Optimum Wellness (GROWell)

NCT02904473 | Completed

• 1 other identifier: Pro00071547
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to assess the feasibility, acceptability and preliminary efficacy of the GROWell diet intervention. The objective of this study is to determine whether the GROWell intervention can help transition women from consuming a Western diet to consuming a prudent diet (characterized by consumption of primarily fruits, vegetables, healthy fats, lean proteins, and whole grains) during pregnancy. Efficacy will be measured as change in dietary components, using a Food Frequency Questionnaire (FFQ) at baseline and at a follow up visit at 37 weeks gestation. The GROWell intervention is a mobile health technology that uses interactive text messaging and dietician coaching calls, and may be effective in transitioning pregnant women from a Western to a prudent diet during an approximately 6 month intervention period. GROWell results will be measured against an Attention Support Control (ASC) arm, where participants will receive messaging that is pregnancy rather than diet focused, and a Usual Care (USC) arm, where participants will not receive text messages or study coaching. Results from this study will be used to support a grant submission for a larger study, aiming to investigate the GROWell intervention and prudent diet consumption as preventatives against postpartum depression.

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (3)

• Feasibility of the GROWell intervention

  Feasibility will be assessed based on the number and percent of women enrolled vs. approached, vs. completing all study assessments.

  37 Weeks Gestation

• Acceptability of the GROWell intervention

  Acceptability measures are participant adherence to digital communications and coaching calls. Subjects will also rate the intervention regarding perceived helpfulness, relationship with their coach, etc.

  37 Weeks Gestation

• Efficacy- change in dietary components from Baseline to 37 Weeks Gestation

  Efficacy will be measured as change in dietary components between the arms, as reported in a Food Frequency Questionnaire (FFQ) reflecting Western or prudent intake over the intervention period. Switching from a Western to a prudent diet is defined as consuming a prudent diet on most days, as determined by questionnaire responses.

  Baseline to 37 Weeks Gestation

Study Arms (3)

GROWell

EXPERIMENTAL

GROWell incorporates 4 elements: phone coaching, goal setting, self-monitoring of behavior and skills training. These interactions take place on a study subject's cell phone, through text messaging, and phone calls with a dietician coach. At study initiation, the subject takes a short survey, after which the intervention algorithm assigns up to 4 tailored behavior change goals from the GROWell library. Goals are tailored to the subject's needs as indicated by the initial survey. Subjects self-monitor adherence weekly via text, responding to prompts from the system regarding their level of success with a given goal. Via text they receive immediate tailored feedback regarding their current adherence and long-term progress.

Other: GROWell

Attention Support Control (ASC)

NO INTERVENTION

The ASC control arm of the study involves one coaching call at baseline, regarding prenatal diet. Weekly text or IVR messages will focus on pregnancy, labor, delivery, and early infancy education.

Usual Care (USC)

NO INTERVENTION

The USC will receive no intervention. They will simply complete baseline and follow-up CASI and blood draw.

Interventions

GROWell OTHER

The GROWell intervention is a mobile health technology, including diet tracking, skills training and tailored feedback based on digital and human support strategies. Its message content is geared toward healthy diet change during pregnancy.

GROWell

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 44
• Read and understand English
• Receiving prenatal care at Duke Medicine
• Prepregnancy BMI ≥25 and \<35
• Within 14 to \<20 weeks gestation
• Singleton, uncomplicated pregnancy \[no preexisting diabetes, hypertension, etc.\]
• Non-smoking for at least 6 months
• Nulliparous, or \>24 months since previous pregnancy
• No current depression as documented in the medical record
• Has a cell phone with texting capability \[smartphone not required\], and is willing to use it at their expense for study purposes

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Leigh Ann Simmons, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 19, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 15, 2019

Record last verified: 2018-10

Locations

US (1)