Trial Outcomes & Findings for MI-CBT Adherence Program for Lifestyle Interventions in Older Adults (NCT NCT04817176)
NCT ID: NCT04817176
Last Updated: 2025-02-14
Results Overview
Retention in the clinical intervention as assessed by percent of attendance at the intervention groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
6-weeks
Results posted on
2025-02-14
Participant Flow
Participant milestones
| Measure |
MI-CBT KNA Program
The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program: Experimental Arm: The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
|
KN Information-Only Program
6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Ketogenic Nutrition Program: Active Comparator Arm: 6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
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|---|---|---|
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Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MI-CBT Adherence Program for Lifestyle Interventions in Older Adults
Baseline characteristics by cohort
| Measure |
MI-CBT KNA Program
n=29 Participants
The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program: Experimental Arm: The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
|
KN Information-Only Program
n=29 Participants
6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Ketogenic Nutrition Program: Active Comparator Arm: 6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
72.59 years
STANDARD_DEVIATION 6 • n=5 Participants
|
73.24 years
STANDARD_DEVIATION 6.77 • n=7 Participants
|
72.91 years
STANDARD_DEVIATION 6.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-weeksRetention in the clinical intervention as assessed by percent of attendance at the intervention groups
Outcome measures
| Measure |
MI-CBT KNA Program
n=29 Participants
The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program: Experimental Arm: The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
|
KN Information-Only Program
n=29 Participants
6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Ketogenic Nutrition Program: Active Comparator Arm: 6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
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|---|---|---|
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Retention
|
90.6 percentage of participants
|
76.6 percentage of participants
|
PRIMARY outcome
Timeframe: 6-weeksAcceptability will be assessed using the Client Satisfaction Questionnaire - 8, item 1, rated 1 (poor) - 4 (excellent) (How would you rate the quality of service you received?).
Outcome measures
| Measure |
MI-CBT KNA Program
n=26 Participants
The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program: Experimental Arm: The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
|
KN Information-Only Program
n=24 Participants
6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Ketogenic Nutrition Program: Active Comparator Arm: 6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
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|---|---|---|
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Acceptability
|
3.65 units on a scale (1-4)
Standard Deviation 0.57
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3.6 units on a scale (1-4)
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: 5 weeksParticipants will show measurable levels of ketones using at-home urinalysis test strips by week 5 of the intervention, as evidenced by greater than trace amounts of ketones on the urine test strips (i.e., \>5mg/dl).
Outcome measures
| Measure |
MI-CBT KNA Program
n=25 Participants
The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program: Experimental Arm: The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
|
KN Information-Only Program
n=24 Participants
6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Ketogenic Nutrition Program: Active Comparator Arm: 6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
|
|---|---|---|
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Ketosis (Adherence)
|
17.32 6-week average urine ketone levels mg/dl
Standard Deviation 14.41
|
10.54 6-week average urine ketone levels mg/dl
Standard Deviation 0.089
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: participants must report pain at screening to be included in analyses
Pain intensity was measured using 4 items in the BPI with possible responses ranging from "0=No Pain" to "10=Pain as Bad as You Can Imagine." Items included pain experienced "at its worst in the last 24 hours" and "pain on average" which were used to measure the magnitude of pain experienced by participants. Pain intensity was calculated as the mean of the 4 items in the BPI with total scores ranging from 0-10 and higher scores indicating worse pain intensity. Changes in pain intensity was calculated by subtracting the baseline total pain intensity score from the 6-week pain intensity score, with a higher negative value indicating greater improvement in pain intensity over time
Outcome measures
| Measure |
MI-CBT KNA Program
n=9 Participants
The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program: Experimental Arm: The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
|
KN Information-Only Program
n=11 Participants
6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Ketogenic Nutrition Program: Active Comparator Arm: 6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
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|---|---|---|
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Brief Pain Inventory, Pain Intensity Scale
|
-0.111 score on a scale
Standard Deviation 1.4
|
-0.159 score on a scale
Standard Deviation 1.2
|
Adverse Events
MI-CBT KNA Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
KN Information-Only Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Julia Sheffler
Florida State University College of Medicine
Phone: 850-644-4199
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place