Trial Outcomes & Findings for An Addiction-Based Mobile Health Weight Loss Intervention With Coaching (NCT NCT03500835)
NCT ID: NCT03500835
Last Updated: 2024-12-06
Results Overview
Mean change in excess BMI percent over the 95th percentile (%BMIp95) over the study period compared at 6 months to baseline. value at 6 months minus value at baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
161 participants
Primary outcome timeframe
6 months
Results posted on
2024-12-06
Participant Flow
Parents were not enrolled. Only adolescents provided informed consent to enroll in the study.
Participant milestones
| Measure |
App Plus Coaching (AC)
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
Coaching: a. 6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction.
b. Daily Weighing c. Daily Text messages from Coach d. Weekly 15 minute phone meetings with Coach e. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent
|
App Alone (AA)
6 month addiction model based weight loss intervention in the form of an iPhone app.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
|
Clinic
In-Clinic Multi-disciplinary monthly weight management program. Curriculum adapted from the KidsNFitness Program and administered by an MD, RD, Psychologist and Health Educator over 90 minute sessions
Clinic: Modified KidsNFitness: a. 6 month in-clinic, evidence-based, multi-disciplinary intervention b. 90 minute sessions, in clinic that occur every month for 6 months c. Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
54
|
|
Overall Study
COMPLETED
|
37
|
23
|
42
|
|
Overall Study
NOT COMPLETED
|
17
|
30
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Addiction-Based Mobile Health Weight Loss Intervention With Coaching
Baseline characteristics by cohort
| Measure |
App Plus Coaching (AC)
n=54 Participants
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
Coaching: a. 6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction.
b. Daily Weighing c. Daily Text messages from Coach d. Weekly 15 minute phone meetings with Coach e. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent
|
App Alone (AA)
n=53 Participants
6 month addiction model based weight loss intervention in the form of an iPhone app.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
|
Clinic
n=54 Participants
In-Clinic Multi-disciplinary monthly weight management program. Curriculum adapted from the KidsNFitness Program and administered by an MD, RD, Psychologist and Health Educator over 90 minute sessions
Clinic: Modified KidsNFitness: a. 6 month in-clinic, evidence-based, multi-disciplinary intervention b. 90 minute sessions, in clinic that occur every month for 6 months c. Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
15 years
n=5 Participants
|
16 years
n=7 Participants
|
16 years
n=5 Participants
|
16 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
53 participants
n=7 Participants
|
54 participants
n=5 Participants
|
161 participants
n=4 Participants
|
|
Body Mass Index Z-score
|
2.2 Z-score
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.2 Z-score
STANDARD_DEVIATION 0.5 • n=7 Participants
|
2.3 Z-score
STANDARD_DEVIATION 0.4 • n=5 Participants
|
2.2 Z-score
STANDARD_DEVIATION 0.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsMean change in excess BMI percent over the 95th percentile (%BMIp95) over the study period compared at 6 months to baseline. value at 6 months minus value at baseline
Outcome measures
| Measure |
App Plus Coaching (AC)
n=37 Participants
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
Coaching: a. 6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction.
b. Daily Weighing c. Daily Text messages from Coach d. Weekly 15 minute phone meetings with Coach e. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent
|
App Alone (AA)
n=23 Participants
6 month addiction model based weight loss intervention in the form of an iPhone app.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
|
Clinic
n=42 Participants
In-Clinic Multi-disciplinary monthly weight management program. Curriculum adapted from the KidsNFitness Program and administered by an MD, RD, Psychologist and Health Educator over 90 minute sessions
Clinic: Modified KidsNFitness: a. 6 month in-clinic, evidence-based, multi-disciplinary intervention b. 90 minute sessions, in clinic that occur every month for 6 months c. Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months.
|
|---|---|---|---|
|
%BMIp95
|
-1.9 percent
Standard Deviation 1
|
-1.2 percent
Standard Deviation 1.2
|
-1.5 percent
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Each groups' implementation cost was evaluated
Real life economic analysis of the intervention arms compared to each other and in in-clinic intervention. The following data were collected throughout the study period to assess the implementation requirements (cost and labour) for each intervention arm: personnel time required for intervention implementation (including training time, visit time and preparation time), intervention specific equipment and maintenance, and cost of each activity per participant for the 6-month intervention period. A full cost-analysis evaluation of the intervention implementation is currently underway. Total accrued cost over the 6 month period compared to the other intervention.
Outcome measures
| Measure |
App Plus Coaching (AC)
n=37 Participants
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
Coaching: a. 6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction.
b. Daily Weighing c. Daily Text messages from Coach d. Weekly 15 minute phone meetings with Coach e. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent
|
App Alone (AA)
n=23 Participants
6 month addiction model based weight loss intervention in the form of an iPhone app.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
|
Clinic
n=42 Participants
In-Clinic Multi-disciplinary monthly weight management program. Curriculum adapted from the KidsNFitness Program and administered by an MD, RD, Psychologist and Health Educator over 90 minute sessions
Clinic: Modified KidsNFitness: a. 6 month in-clinic, evidence-based, multi-disciplinary intervention b. 90 minute sessions, in clinic that occur every month for 6 months c. Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months.
|
|---|---|---|---|
|
Cost Analysis
|
2076 US dollars
Standard Deviation 150
|
1122 US dollars
Standard Deviation 135
|
4034 US dollars
Standard Deviation 178
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: YFAS-c was completed at baseline and throughout the study period. It has been well assessed in adolescents with obesity that up to 25-30% report positive YFAS-c scores consistent with addictive like eating behaviors.
Yale Food Addiction Scale-Children (YFAS-c). The 25-tem scale assesses seven diagnostic criteria for substance dependence as it relates to eating. Items are answered on a 7-point Likert Scale ranging from 0 (never) to 7 (every day). Participants who report three or more symptoms and clinically significant impairment meet the criteria for food addiction (FA). The YFAS-c has shown good test-retest reliability. Reliability analyses have shown high internal consistency (Cronbach's alpha = 0.81) in the general paediatric population, and test-retest reliability between 0.79 and 0.84 in studies conducted in ethnically diverse paediatric populations. Total Score: The total score on the YFAS ranges from 0 to 11. A score of 0 indicates no symptoms of food addiction, while a score of 11 indicates the highest level of symptoms consistent with food addiction. Total Score Range: 0 to 11 Loss of Control Subscale Range: 0 to 5 Persistent Use Subscale Range: 0 to 6
Outcome measures
| Measure |
App Plus Coaching (AC)
n=37 Participants
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
Coaching: a. 6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction.
b. Daily Weighing c. Daily Text messages from Coach d. Weekly 15 minute phone meetings with Coach e. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent
|
App Alone (AA)
n=23 Participants
6 month addiction model based weight loss intervention in the form of an iPhone app.
App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.
|
Clinic
n=42 Participants
In-Clinic Multi-disciplinary monthly weight management program. Curriculum adapted from the KidsNFitness Program and administered by an MD, RD, Psychologist and Health Educator over 90 minute sessions
Clinic: Modified KidsNFitness: a. 6 month in-clinic, evidence-based, multi-disciplinary intervention b. 90 minute sessions, in clinic that occur every month for 6 months c. Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months.
|
|---|---|---|---|
|
Yale Food Addiction Scale
|
-0.5 score on a scale
Interval -0.5 to 0.0
|
-0.5 score on a scale
Interval -1.5 to 0.0
|
0 score on a scale
Interval -1.0 to 0.0
|
Adverse Events
App Plus Coaching (AC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
App Alone (AA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinic
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place