Health, Aging and Later-Life Outcomes
- Conditions
- Aging
- Interventions
- Behavioral: Time-restrictedBehavioral: Remote Caloric RestrictionBehavioral: In-Person Caloric Restriction
- Registration Number
- NCT05424042
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time-Restricted Eating Arm Time-restricted 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. Remote Caloric Restriction Arm Remote Caloric Restriction 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. In-Person Caloric Restriction Arm In-Person Caloric Restriction 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.
- Primary Outcome Measures
Name Time Method TRE sustainability Month 9 At least 75% of participants eating within window on \>80% of days
Retention of study participants Month 9 Retention \> 85%
Degree of sustained CR Month 9 CR \> 10%
- Secondary Outcome Measures
Name Time Method Body Weight Change From Baseline to Month 6, and From Baseline to 9 Months Assessed using home scales.
Changes in Fat From Baseline to Month 9 Assessed by (Dual-Energy X-Ray Absorptiometry) DXA.
Change in Resting Energy Expenditure From Baseline to Month 9 Assessed by Indirect Calorimetry
Change in Energy Intake From Baseline to Month 9 Using doubly-labeled water (DLW). Energy intake will be calculated from Total Energy Expenditure (TEE) assessed by DLW and change in body energy stores (measured by body weight and/or DXA) according to the equation: Energy Intake = TEE + Change in body energy stores
Change in Total Muscle Mass From Baseline to Month 9 Assessed by d3 creatine (d3cr)
Change in Cognitive Function--MoCA From baseline to Month 9 Total score ranges from 0-30 with a higher score denoting better cognitive function.
Change in Age-Related Biomarkers--tumor necrosis factor soluble receptor I (TNFRI) From Baseline to 9 Months Change in Age-Related Biomarkers-- CRP from serum From Baseline to 9 Months Change in Bone Mineral Density From Baseline to Month 9 Assessed by DXA
Physical Function--Change in Walk Time From Baseline to Month 9 400m walk - assessed in minutes/secs (unlimited time)
Physical Function--Change in Grip Strength From Baseline to Month 9 measured in kg (0-90kg)
Physical Function--Change in eSPPB From Baseline to Month 9 Change in overall physical performance with total score ranging from 0 to 12 with a higher score denoting better physical function.
Change in Age-Related Biomarkers--Fasting Insulin From Baseline to 9 Months Changes in Lean Body Mass From Baseline to Month 9 Assessed by DXA
Change in Physical Activity Energy Expenditure From Baseline to Month 9 Assessed by ActivPAL
Change in Self-Reported Energy Intake From Baseline to Month 9 Data will be collected and nutrients and food groups analyzed using the publicly available National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment tool.
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 and CRP from serum
Trial Locations
- Locations (1)
Atrium Health Wake Forest Baptist Hospital
🇺🇸Winston-Salem, North Carolina, United States