Trial Outcomes & Findings for Internet Assisted Obesity Treatment Enhanced With Financial Incentives (NCT NCT02688621)

NCT ID: NCT02688621

Last Updated: 2021-10-29

Results Overview

Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 418 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-10-29

Participant Flow

Participant milestones

Measure	Internet Only Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Overall Study STARTED	212	206
Overall Study COMPLETED	172	188
Overall Study NOT COMPLETED	40	18

Reasons for withdrawal

Measure	Internet Only Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Overall Study Pregnancy	1	3
Overall Study Lost to Follow-up	38	15
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Internet Assisted Obesity Treatment Enhanced With Financial Incentives

Baseline characteristics by cohort

Measure	Internet Only n=212 Participants Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives n=206 Participants Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing	Total n=418 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 11.14 • n=5 Participants	50 years STANDARD_DEVIATION 11.01 • n=7 Participants	49 years STANDARD_DEVIATION 11.11 • n=5 Participants
Sex: Female, Male Female	194 Participants n=5 Participants	187 Participants n=7 Participants	381 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	210 Participants n=5 Participants	202 Participants n=7 Participants	412 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	63 Participants n=5 Participants	44 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) White	147 Participants n=5 Participants	160 Participants n=7 Participants	307 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	212 participants n=5 Participants	206 participants n=7 Participants	418 participants n=5 Participants
Weight	97.8 kilograms STANDARD_DEVIATION 19.5 • n=5 Participants	95.6 kilograms STANDARD_DEVIATION 15.9 • n=7 Participants	96.7 kilograms STANDARD_DEVIATION 17.7 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.

Outcome measures

Measure	Internet Only n=212 Participants Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives n=206 Participants Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Weight Change Baseline	97.8 kilograms Standard Deviation 19.5	95.6 kilograms Standard Deviation 15.9
Weight Change 6 Months	4.7 kilograms Standard Deviation 6.6	6.4 kilograms Standard Deviation 5.5

SECONDARY outcome

Timeframe: 6 months

Average number of classes attended

Outcome measures

Measure	Internet Only n=212 Participants Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives n=206 Participants Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Class Attendance	16 Number of classes attended Standard Deviation 6.6	18 Number of classes attended Standard Deviation 5.1

SECONDARY outcome

Timeframe: 6 months

Number of days with body weight self reported

Outcome measures

Measure	Internet Only n=212 Participants Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives n=206 Participants Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Self Monitoring of Body Weight	72 Number of days weight self report Standard Deviation 51	115 Number of days weight self report Standard Deviation 43

SECONDARY outcome

Timeframe: 6 months

Number of days reported dietary intake over 6 months

Outcome measures

Measure	Internet Only n=212 Participants Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives n=206 Participants Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Dietary Intake Self Monitoring	85 Number of days dietary intake reported Standard Deviation 54	119 Number of days dietary intake reported Standard Deviation 44

SECONDARY outcome

Timeframe: 6 months

Number of days physical activity reported

Outcome measures

Measure	Internet Only n=212 Participants Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives n=206 Participants Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Self Monitoring of Physical Activity	85 Number of days Physical Activity report Standard Deviation 54	118 Number of days Physical Activity report Standard Deviation 44

SECONDARY outcome

Timeframe: 6 months

Number of Steps/day

Outcome measures

Measure	Internet Only n=212 Participants Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online	Internet + Incentives n=206 Participants Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Steps/Day	7447 number of steps Standard Deviation 2888	8057 number of steps Standard Deviation 2672

Adverse Events

Internet Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Internet + Incentives

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

Doris Ogden

University of Vermont

Phone: 802-656-1960

Email: doris.ogden@uvm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place