Goals for Reaching Optimum Wellness (GROWell)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 3/10/2019 |
| Start Date: | November 2016 |
| End Date: | July 2019 |
Goals for Reaching Optimum Wellness (GROWell): A Pilot Study of a Dietary Intervention During Pregnancy
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.
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.
The GROWell intervention is a mobile health technology, including diet tracking, skills
training and tailored feedback based on digital and human support strategies. Its structure
is based on the iOTA (interactive obesity treatment approach), designed for dietary change,
obesity, and chronic disease management, with message content modified for healthy diet
change during pregnancy.
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 the initiation of the
intervention, the subject takes a short survey, after which the intervention algorithm
assigns up to 4 tailored behavior change goals from the GROWell library. Examples of goals
would be to eliminate fast food from the diet, or to limit red meat. Goals are tailored to
the subject's needs as indicated by the initial survey, so if for example the subject doesn't
eat fast food, that goal is not assigned. The algorithm prioritizes behaviors in highest need
of change, and those for which participant has high self-efficacy and readiness based on the
survey responses. 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.
Feedback includes showing progress trends, reinforcing success, and offering motivational
strategies to support behavior change based on the self-monitoring data. To support the next
week's efforts, the algorithm tailors feedback, selecting content from a skills training
library and sending materials to assist behavior change efforts. Skills training materials
include online handouts, featuring content that discusses the adoption of healthy dietary
changes in pregnancy. A set of skills training materials exists for each goal in the library.
When a subject is assigned a goal, they receive a link to the training materials for that
goal over the phone.
The human support component of the intervention relies in part on the GROWell platform's
interface, which allows diet coaches to view participant data. This information is then used
to inform feedback during coaching calls. These 15-minute conversations will be guided by
principles of motivational interviewing (MI). In each session, the dietician coach and the
subject will discuss self-monitoring data and reinforce its importance, discuss barrier
reduction strategies and skills training content, and engaging community resources. The
GROWell study will implement a series of dietician coaching calls starting weekly for the
first month and decreasing in frequency to biweekly during the study period, totaling
approximately 12 calls depending on delivery date.
The ASC control arm of the study involves more limited intervention. There will be one
coaching call at baseline, regarding prenatal diet. Weekly text or IVR messages will focus on
pregnancy, labor, delivery, and early infancy education.
The USC will receive no intervention. They will simply complete baseline and follow-up
questionnaires.
Participants on all arms may opt to have blood drawn at the baseline visit and the follow up
visit for an optional biomarker study.
training and tailored feedback based on digital and human support strategies. Its structure
is based on the iOTA (interactive obesity treatment approach), designed for dietary change,
obesity, and chronic disease management, with message content modified for healthy diet
change during pregnancy.
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 the initiation of the
intervention, the subject takes a short survey, after which the intervention algorithm
assigns up to 4 tailored behavior change goals from the GROWell library. Examples of goals
would be to eliminate fast food from the diet, or to limit red meat. Goals are tailored to
the subject's needs as indicated by the initial survey, so if for example the subject doesn't
eat fast food, that goal is not assigned. The algorithm prioritizes behaviors in highest need
of change, and those for which participant has high self-efficacy and readiness based on the
survey responses. 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.
Feedback includes showing progress trends, reinforcing success, and offering motivational
strategies to support behavior change based on the self-monitoring data. To support the next
week's efforts, the algorithm tailors feedback, selecting content from a skills training
library and sending materials to assist behavior change efforts. Skills training materials
include online handouts, featuring content that discusses the adoption of healthy dietary
changes in pregnancy. A set of skills training materials exists for each goal in the library.
When a subject is assigned a goal, they receive a link to the training materials for that
goal over the phone.
The human support component of the intervention relies in part on the GROWell platform's
interface, which allows diet coaches to view participant data. This information is then used
to inform feedback during coaching calls. These 15-minute conversations will be guided by
principles of motivational interviewing (MI). In each session, the dietician coach and the
subject will discuss self-monitoring data and reinforce its importance, discuss barrier
reduction strategies and skills training content, and engaging community resources. The
GROWell study will implement a series of dietician coaching calls starting weekly for the
first month and decreasing in frequency to biweekly during the study period, totaling
approximately 12 calls depending on delivery date.
The ASC control arm of the study involves more limited intervention. There will be one
coaching call at baseline, regarding prenatal diet. Weekly text or IVR messages will focus on
pregnancy, labor, delivery, and early infancy education.
The USC will receive no intervention. They will simply complete baseline and follow-up
questionnaires.
Participants on all arms may opt to have blood drawn at the baseline visit and the follow up
visit for an optional biomarker study.
Inclusion Criteria:
- 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
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