A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes
연구 개요
상세 설명
Participants (N = 64) will be randomly assigned to either an episodic future thinking group or control thinking groups. Participants will generate episodic future events or control information, as well as related text-based cues, and will be prompted via smartphone or web application to engage in episodic future or control thinking frequently in their natural environment (e.g., at home or work, before meal times, and in high-risk situations) for a 4-month period. Participants in both groups will be provided with one-on-one, phone-based case management and provided with instructional materials and behavioral tools for weight loss and diabetes management. Instructional materials will include: 1) a modified version of the Traffic Light Diet, which utilizes red, yellow, and green labels for food to guide participants toward the goal of consuming low energy dense, low glycemic, high nutrient dense foods; 2) the Traffic Light Activity Program, which also utilizes red, yellow, and green labels for different levels of caloric expenditure, and 3) tools for self-monitoring of weight, diet, and/or physical activity.
Participants will complete four laboratory-based assessment sessions in which the investigators assess body weight, height, waist and hip circumference, glycemic control (HbA1C), adherence to oral glucose-lowering medication, delay discounting, reinforcing efficacy of food, and blood pressure. These assessments will be completed before the intervention (Week 0), during the intervention (8 weeks), and immediately after the intervention (Week 16), as well after a 2-month post-intervention follow-up (Week 24). The latter three assessments sessions will also include questions to measure participants' perceived effectiveness and ease of use of the intervention. Participants will also complete several remote assessments, including dietary intake and physical activity (during Weeks 0, 8, and 16; via accelerometer), as well as delay discounting and reinforcing efficacy of food (during Weeks 3, 8, and 16).
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Virginia
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Roanoke, Virginia, 미국, 24016
- Fralin Biomedical Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Overweight or obese (BMI of 25 or greater)
- Poorly controlled type 2 diabetes (HbA1C of 8% or greater)
- Prescribed or recommended oral glucose-lowering medication
Exclusion Criteria:
- Current insulin therapy for type 2 diabetes
- History of gestational diabetes
- Pregnant or lactating
- Not ambulatory
- Intellectual impairment
- Unmanaged medical or psychiatric disorder
- Abnormal glucose related to medications (e.g, glucocorticoids)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Episodic future thinking
Participants will generate positive future events and related text cues that will be accessed via an electronic app to engage in episodic future thinking.
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Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.
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가짜 비교기: Control thinking
Participants will generate non-future-oriented information and related text cues that will be accessed via an electronic app to engage in control thinking..
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Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glycemic control
기간: Baseline, 8 weeks, 16 weeks, and 24 weeks
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Glycemic control will be assessed by hemoglobin A1C (HbA1c), a standardized diagnostic measure for type 2 diabetes.
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Baseline, 8 weeks, 16 weeks, and 24 weeks
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Change in weight
기간: Baseline, 8 weeks, 16 weeks, and 24 weeks
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Body weight will be measured using a digital scale.
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Baseline, 8 weeks, 16 weeks, and 24 weeks
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Change in delay discounting
기간: Baseline, 8 weeks, 16 weeks, and 24 weeks
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Delay discounting will be assessed using computerized behavioral tasks.
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Baseline, 8 weeks, 16 weeks, and 24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in dietary intake
기간: Baseline, 8 weeks, 16 weeks, and 24 weeks
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Dietary intake will be assessed by 24-hour food recall, using the Automated Self-Administered 24 (ASA-24) food recalls.
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Baseline, 8 weeks, 16 weeks, and 24 weeks
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Change in medication adherence
기간: Baseline, 8 weeks, 16 weeks, and 24 weeks
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Medication adherence to oral glucose-lowering medication (e.g., metformin) will be assessed by direct observation (pill counts) and by self-report.
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Baseline, 8 weeks, 16 weeks, and 24 weeks
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Change in physical activity
기간: Baseline, 8 weeks, 16 weeks, and 24 weeks
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Duration of physical activity (in minutes) will be measured using an Actigraph accelerometer
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Baseline, 8 weeks, 16 weeks, and 24 weeks
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Change in blood pressure
기간: Baseline, 8 weeks, 16 weeks, and 24 weeks
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Blood pressure will be measured using an automated blood pressure device.
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Baseline, 8 weeks, 16 weeks, and 24 weeks
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Change in waist and hip circumference
기간: Baseline, 8 weeks, 16 weeks, and 24 weeks
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Waist and hip circumference will be assessed by measuring tape.
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Baseline, 8 weeks, 16 weeks, and 24 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceived treatment effectiveness and ease of use
기간: 8 weeks, 16 weeks, and 24 weeks
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Ease of use and perceived treatment effectiveness for each intervention component will be measured using the Ease of Use and Treatment Effectiveness Questionnaire (EUTEQ), a custom-designed questionnaire modified from a previous scale used in treatment for alcohol use disorder.
Scores will be calculated for each intervention component (e.g., episodic thinking, Traffic Light Diet) separately for ease of use and treatment effectiveness.
Scale ranges from 1 (not at all easy to use/effective) to 5 (very easy to use/effective).
Higher scores represent greater ease of use, perceived effectiveness.
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8 weeks, 16 weeks, and 24 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jeff S Stein, PhD, Virginia Tech Carilion School of Medicine and Research Institute
- 수석 연구원: John W Epling, MD, Carilion Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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