Health, Aging and Later-Life Outcomes Pilot Trial (HALLO-P): A 9-month Randomized Pilot Trial of 3 Nutritional Interventions in 120 Older Adults With an Indication for Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of Participants That Sustained >10% Caloric Restriction
研究概览
简要总结
The purpose of this pilot research is to test the feasibility of two interventions focused on either reducing total calorie intake or reducing the total time that calories are ingested each day in older adults. Participation in this research will involve visits to our clinic for testing and weekly intervention visits (in-person or remote depending on group assignment) for nine months with total participation lasting about a year.
详细描述
This pilot study is part of a larger planning process to design a full-scale randomized trial to evaluate the long-term effects of caloric restriction (CR) and time restricted eating (TRE) on the health of older adults. The specific objective of the HALLO-P is to collect data to inform the design of the full-scale randomized trial to evaluate the long-term effects of caloric restriction and time restricted eating in older adults. The pilot is a 9-month clinical trial. The pilot data will be used to refine recruitment criteria, estimate recruitment yields, and refine intervention approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Staff who will assess outcomes at follow up visits will be blinded to group assignment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling men and women residing in Forsyth County, NC or surrounding counties
- •obesity (BMI = 30 - < =40 kg/m2) or are overweight (BMI = 27 - <30 kg/m2 with an indication for weight loss (e.g., hypertension, hyperlipidemia, elevated waist girth, controlled diabetes)
排除标准
- •persons for whom the interventions are potentially unsafe
- •history of eating or nutritional disorders
- •those who are likely to drop out due to severe chronic illness or other reasons
- •who show inability to perform self-monitoring activities required by the interventions
- •those doing shift work because disturbances in circadian cycles may interfere with TRE
- •uncontrolled or previously undetected diabetes because disease management may interfere with the interventions
- •certain medical treatments may complicate outcome interpretation
研究组 & 干预措施
In-Person Caloric Restriction Arm
This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.
干预措施: In-Person Caloric Restriction (Behavioral)
Remote Caloric Restriction Arm
This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.
干预措施: Remote Caloric Restriction (Behavioral)
Time-Restricted Eating Arm
This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
干预措施: Time-restricted (Behavioral)
结局指标
主要结局
Number of Participants That Sustained >10% Caloric Restriction
时间窗: Month 9
Ability of participants to sustain Caloric Restriction \>10%
Ability to Maintain Time Restricted Eating (TRE) Intervention
时间窗: Month 9
This will measure the sustainability in a 9 month period of time and will be reported as the percentage of day eating within \<= 8.5 hour window which is pre-specified for each participant.
Number of Participants Who Were Retained
时间窗: Month 9
Retention \> 85%
次要结局
- Body Weight Change(From Baseline to Month 6, and From Baseline to 9 Months)
- Changes in Lean Body Mass(From Baseline to Month 9)
- Change in Bone Mineral Density(From Baseline to Month 9)
- Change in Resting Energy Expenditure(From Baseline to Month 9)
- Change in Physical Activity Energy Expenditure(From Baseline to Month 9)
- Change in Energy Intake(From Baseline to Month 9)
- Change in Total Muscle Mass(From Baseline to Month 9)
- Change in Self-Reported Energy Intake(From Baseline to Month 9)
- Physical Function--Change in Walk Time(From Baseline to Month 9)
- Physical Function--Change in Grip Strength(From Baseline to Month 9)
- Physical Function--Change in eSPPB(From Baseline to Month 9)
- Change in Cognitive Function--MoCA(From baseline to Month 9)
- Change in Age-Related Biomarkers--Fasting Insulin(From Baseline to 9 Months)
- Change in Age-Related Biomarkers--interleukin-6 (IL-6)(From Baseline to 9 Months)
- Change in Age-Related Biomarkers--cystatin C(From Baseline to 9 Months)
- Physical Function--Change in Grip Strength(From Baseline to Month 9)
- Body Weight Change(From Baseline to Month 6, and From Baseline to 9 Months)
- Changes in Fat Mass(From Baseline to Month 9)
- Changes in Lean Body Mass(From Baseline to Month 9)
- Change in Bone Mineral Density(From Baseline to Month 9)
- Change in Resting Energy Expenditure(From Baseline to Month 9)
- Change in Physical Activity Energy Expenditure(From Baseline to Month 9)
- Change in Energy Intake(From Baseline to Month 9)
- Change in Total Muscle Mass(From Baseline to Month 9)
- Change in Self-Reported Energy Intake(From Baseline to Month 9)
- Physical Function--Change in Walk Time(From Baseline to Month 9)
- Physical Function--Change in eSPPB(From Baseline to Month 9)
- Change in Cognitive Function--MoCA(From baseline to Month 9)
- Change in Age-Related Biomarkers--Fasting Insulin(From Baseline to 9 Months)
- Change in Age-Related Biomarkers--interleukin-6 (IL-6)(From Baseline to 9 Months)
- Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI)(From Baseline to 9 Months)
- Change in Age-Related Biomarkers--cystatin C(From Baseline to 9 Months)
- Change in Age-Related Biomarkers-- CRP From Serum(From Baseline to 9 Months)