Pregnant WomenNCT02904473
Goals for Reaching Optimum Wellness (GROWell)
A study testing GROWell in people with Pregnant Women, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- GROWell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.]
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Pregnant Women
- Being tested
- GROWell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROWellOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 37 Weeks Gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Ann Simmons, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904473
- Sponsor's protocol ID
- Pro00071547
- Status last verified
- Oct 2018
- First submitted
- 31 Aug 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goals for Reaching Optimum Wellness (GROWell): A Pilot Study of a Dietary Intervention During Pregnancy
- ClinicalTrials.gov ID
- NCT02904473
- Acronym / sponsor ID
- Pro00071547
- Conditions
- Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROWell | Experimental | Other: GROWellGROWell 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. |
| 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GROWellThe 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. | Other | GROWell |
Primary outcome
Feasibility of the GROWell intervention
Time frame: 37 Weeks Gestation
Feasibility will be assessed based on the number and percent of women enrolled vs. approached, vs. completing all study assessments.
Acceptability of the GROWell intervention
Time frame: 37 Weeks Gestation
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.
Efficacy- change in dietary components from Baseline to 37 Weeks Gestation
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Ann Simmons, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GROWell in people with Pregnant Women, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the GROWell intervention (time frame: 37 Weeks Gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.