Behavioral Economics for Activity Motivation in Adolescents and Young Adults With Prediabetes and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in Moderate to Vigorous Physical Activity (MVPA)
研究概览
简要总结
There is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (AYA) with type 2 diabetes (T2D), who often have very low levels of physical activity. The BEAM Trial is a mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes.
详细描述
Some secondary outcome measures from the protocol were inadvertently left out when creating the registration and have been added with the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Males or females age 13 to 22 years.
- •2) Overweight or obese (BMI ≥85th percentile for age/sex, or ≥25 kg/m2 for participants ≥18 years)
- •3) Diagnosis with prediabetes or type 2 diabetes
- •4) Consent (subjects 18 and older), Parental/guardian permission (subjects 13-17), assent (subjects 13-17)
- •5) Willingness to wear Fitbit during waking hours daily for duration of run-in and intervention.
- •6) Possession of a smartphone.
排除标准
- •1) Potential subject unable to speak or read in English
- •2) Severe cognitive impairment
- •3) Permanent or temporary physical disability that impairs ambulation or precludes engagement in MVPA
- •4) Current pregnancy
- •5) Previously-diagnosed or current restrictive or purging eating disorder
- •6) Moderate to vigorous physical activity (MVPA) >30 minutes per day or Fitbit wear < 4 days during second week of 2-week run-in period
研究组 & 干预措施
Condition 1
1RLD=One text per day, ramped goal, loss incentive, daily goal time period.
干预措施: 1RLD (Behavioral)
Condition 14
2FLW=Two texts per day, fixed goal, loss incentive, weekly goal time period.
干预措施: 2FLW (Behavioral)
Condition 2
1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
干预措施: 1RLW (Behavioral)
Condition 3
1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
干预措施: 1RGD (Behavioral)
Condition 4
1RGW=One text per day, ramped goal, gain incentive, weekly goal time period.
干预措施: 1RGW (Behavioral)
Condition 5
2RLD=Two texts per day, ramped goal, loss incentive, daily goal time period.
干预措施: 2RLD (Behavioral)
Condition 6
2RLW=Two texts per day, ramped goal, loss incentive, weekly goal time period.
干预措施: 2RLW (Behavioral)
Condition 7
2RGD=Two texts per day, ramped goal, gain incentive, daily goal time period.
干预措施: 2RGD (Behavioral)
Condition 8
2RGW=Two texts per day, ramped goal, gain incentive, weekly goal time period.
干预措施: 2RGW (Behavioral)
Condition 9
1FLD=One text per day, fixed goal, loss incentive, daily goal time period.
干预措施: 1FLD (Behavioral)
Condition 10
1FLW=One text per day, fixed goal, loss incentive, weekly goal time period.
干预措施: 1FLW (Behavioral)
Condition 11
1FGD=One text per day, fixed goal, gain incentive, daily goal time period.
干预措施: 1FGD (Behavioral)
Condition 12
1FGW=One text per day, fixed goal, gain incentive, weekly goal time period.
干预措施: 1FGW (Behavioral)
Condition 13
2FLD=Two texts per day, fixed goal, loss incentive, daily goal time period.
干预措施: 2FLD (Behavioral)
Condition 15
2FGD=Two texts per day, fixed goal, gain incentive, daily goal time period.
干预措施: 2FGD (Behavioral)
Condition 16
2FGW=Two texts per day, fixed goal, gain incentive, weekly goal time period.
干预措施: 2FGW (Behavioral)
结局指标
主要结局
Change in Moderate to Vigorous Physical Activity (MVPA)
时间窗: 12 weeks
Effects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline
次要结局
- Change in Daily Step Count(12 weeks)
- Change in BMI Z-score(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Plasma Glucose(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Insulin(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Hemoglobin A1c(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Triglycerides(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Low-density Lipoprotein (LDL)(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in High-density Lipoprotein (HDL)(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in ALT(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Daily Step Count(12 weeks)
- Change in BMI Z-score(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Plasma Glucose(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Insulin(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Hemoglobin A1c(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Triglycerides(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in Low-density Lipoprotein (LDL)(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in High-density Lipoprotein (HDL)(From baseline to follow-up in-person study visits, separated by 3 months)
- Change in ALT(From baseline to follow-up in-person study visits, separated by 3 months)
研究者
Mary Ellen Vajravelu, MD
Assistant Professor
University of Pittsburgh