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Caloric Restriction for Healthy Aging (HALLO-P Trial)
N/A
Waitlist Available
Led By W. Jack Rejeski, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to month 6, and from baseline to 9 months
Awards & highlights
HALLO-P Trial Summary
This trial is testing whether reducing calories or the time spent eating leads to better health outcomes in older adults.
Who is the study for?
This trial is for adults living in or near Forsyth County, NC who are overweight or obese but generally healthy. Ideal candidates should not have eating disorders, severe chronic illnesses, uncontrolled diabetes, or work night shifts. They must be able to self-monitor their health and follow the study's requirements.Check my eligibility
What is being tested?
The study tests two dietary approaches over a year: one group will reduce how many calories they eat with guidance either in-person or remotely; another group will limit the hours during which they eat each day (time-restricted eating).See study design
What are the potential side effects?
Potential side effects from caloric restriction may include feelings of hunger, fatigue, irritability, and possible nutrient deficiencies if not monitored properly. Time-restricted eating could disrupt normal eating patterns leading to similar issues.
HALLO-P Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to month 6, and from baseline to 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to month 6, and from baseline to 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Degree of sustained CR
Retention of study participants
TRE sustainability
Secondary outcome measures
Body Weight Change
Change in Age-Related Biomarkers-- CRP from serum
Change in Age-Related Biomarkers--Fasting Insulin
+15 moreOther outcome measures
Community Interest
Intervention Delivery Costs
Participants with Inter-current Health Events
+1 moreHALLO-P Trial Design
3Treatment groups
Experimental Treatment
Group I: Time-Restricted Eating ArmExperimental Treatment1 Intervention
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.
Group II: Remote Caloric Restriction ArmExperimental Treatment1 Intervention
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.
Group III: In-Person Caloric Restriction ArmExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,117 Total Patients Enrolled
9 Trials studying Aging
5,442 Patients Enrolled for Aging
W. Jack Rejeski, PhDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
432 Total Patients Enrolled
Stephen B. Kritchevsky, PhDPrincipal InvestigatorWake Forest University Health Sciences
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My current medications won't affect the trial's results.My diabetes is not under control or was recently discovered.
Research Study Groups:
This trial has the following groups:- Group 1: Time-Restricted Eating Arm
- Group 2: In-Person Caloric Restriction Arm
- Group 3: Remote Caloric Restriction Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on individuals who can join this experiment?
"Confirmed. According to data posted on clinicaltrials.gov, this particular research project was initially published in July 5th 2022 and has since been updated as recently as August 2nd 2022. As of now, the program is recruiting 120 participants across a single medical centre."
Answered by AI
Are there any slots available to enroll in this experiment?
"Yes, clinicaltrials.gov confirms that the research is actively recruiting candidates. It was posted on July 5th 2022 and has been updated most recently on August 2nd 2022. This medical project aims to enroll 120 participants from one site."
Answered by AI
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