이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Goals for Reaching Optimum Wellness (GROWell)

2019년 8월 14일 업데이트: Duke University

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

34

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • Duke University Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: GROWell
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.
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.
간섭 없음: Attention Support Control (ASC)
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.
간섭 없음: Usual Care (USC)
The USC will receive no intervention. They will simply complete baseline and follow-up CASI and blood draw.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of the GROWell intervention
기간: 37 Weeks Gestation
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
기간: 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.
37 Weeks Gestation
Efficacy- change in dietary components from Baseline to 37 Weeks Gestation
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Leigh Ann Simmons, PhD, Duke University School of Nursing

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 11월 1일

기본 완료 (실제)

2019년 8월 1일

연구 완료 (실제)

2019년 8월 1일

연구 등록 날짜

최초 제출

2016년 8월 31일

QC 기준을 충족하는 최초 제출

2016년 9월 13일

처음 게시됨 (추정)

2016년 9월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 8월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 8월 14일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Pro00071547

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

GROWell에 대한 임상 시험

구독하다