iREACH3: Internet Assisted Obesity Treatment Enhanced With Financial Incentives

• Sponsor: University of Vermont (Other)
• Overall Status: Completed
• CT.gov ID: NCT02688621
• Collaborator: University of South Carolina (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 418
• Locations: 2
• Arms: 2
• Actual Duration (Months): 39.7
• Patients Per Site: 209
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

The investigators propose a randomized controlled trial to evaluate whether the addition of financial incentives to a high-quality, online behavioral weight loss intervention produces better weight losses than the online treatment alone.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Internet Only; Behavioral: Internet + Incentives	N/A

Detailed Description

Overweight and obese but otherwise healthy participants (N=416) will be recruited in approximately equal numbers at two clinical centers, the University of South Carolina and the University of Vermont. Eligible participants will be randomized to one of two conditions: 1) an 18-month, 36-session group Internet behavioral weight control treatment (Internet Only) which replicates the intervention the investigators have implemented previously; or 2) the same 18-month, 36-session group Internet treatment plus financial incentives for performance of 3 key self-management behaviors (Internet+ Incentive). Both conditions will have access to the same web-based intervention platform and the same counselor-delivered intervention elements; the presence of economic incentives for behavioral and weight goals is the only difference between the conditions. Assessments will be conducted at Baseline, 2, 6, 12 and 18 months. Cost data will be collected to inform cost effectiveness evaluations.

Study Design

• Study Type: Interventional
• Actual Enrollment: 418 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Internet Assisted Obesity Treatment Enhanced With Financial Incentives
• Actual Study Start Date: Apr 11, 2016
• Actual Primary Completion Date: Aug 2, 2019
• Actual Study Completion Date: Aug 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Internet Only; 18 month behavioral weight loss intervention delivered online
Experimental: 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.	Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. Weight Change [6 months]

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

Secondary Outcome Measures

1. Class Attendance [6 months]

   Average number of classes attended

2. Self Monitoring of Body Weight [6 months]

   Number of days with body weight self reported

3. Dietary Intake Self Monitoring [6 months]

   Number of days reported dietary intake over 6 months

4. Self Monitoring of Physical Activity [6 months]

   Number of days physical activity reported

5. Steps/Day [6 months]

   Number of Steps/day

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• over 18

• BMI between 25 and 50

• Not currently pregnant or pregnant in the previous 6 months and currently breastfeeding or planning on becoming pregnant in 18 months

• Have a computer at home or at work with flashplayer, access to the internet, and a smart phone (to allow use of step counting aps)

• Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component

• Not enrolled in another weight reduction program

• Not currently on medication that would affect weight loss

Exclusion Criteria:

• had a heart attack or stroke in the previous six months

• had weight loss surgery

• lost 10 pounds or more in the previous 6 months

• currently taking medications for weight loss

• required by their doctor to follow a special diet (other than low fat)

• planning to move out of the area within 18 months

• schedule conflicts making it difficult to attend online "chats"

• live more than 60 minutes driving distance from either University of South Carolina or University of Vermont campuses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Carolina	Columbia	South Carolina	United States	29208
2	Behavioral Weight Management Program/Univ of Vermont	Burlington	Vermont	United States	05405

Sponsors and Collaborators

• University of Vermont
• University of South Carolina
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Delia Smith West, PhD, University of South Carolina
• Principal Investigator: Jean R Harvey, PhD, University of Vermont

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 6, 2015
• Informed Consent Form - Dec 4, 2015

More Information

Publications

None provided.

• Responsible Party: Jean R. Harvey, PhD, RD, Principal Investigator, University of Vermont
• ClinicalTrials.gov Identifier: NCT02688621
• Other Study ID Numbers: CHRBS 15-259; R01DK056746
• First Posted: Feb 23, 2016
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jean R. Harvey, PhD, RD, Principal Investigator, University of Vermont: weight loss; financial incentives; internet weight loss
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Internet Only	Internet + Incentives
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	212	206
COMPLETED	172	188
NOT COMPLETED	40	18

Baseline Characteristics

Arm/Group Title	Internet Only	Internet + Incentives	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	212	206	418
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48 (11.14)	50 (11.01)	49 (11.11)
Sex: Female, Male (Count of Participants)
Female	194 91.5%	187 90.8%	381 91.1%
Male	18 8.5%	19 9.2%	37 8.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 0.9%	4 1.9%	6 1.4%
Not Hispanic or Latino	210 99.1%	202 98.1%	412 98.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.5%	1 0.2%
Asian	1 0.5%	1 0.5%	2 0.5%
Native Hawaiian or Other Pacific Islander	1 0.5%	0 0%	1 0.2%
Black or African American	63 29.7%	44 21.4%	107 25.6%
White	147 69.3%	160 77.7%	307 73.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	212 100%	206 100%	418 100%
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	97.8 (19.5)	95.6 (15.9)	96.7 (17.7)

Outcome Measures

1. Primary Outcome

Title	Weight Change
Description	Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet Only	Internet + Incentives
Arm/Group Description	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	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
Measure Participants	212	206
Baseline	97.8 (19.5)	95.6 (15.9)
6 Months	4.7 (6.6)	6.4 (5.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Internet Only, Internet + Incentives
	Comments	The study was designed to detect a 2.2-kg group weight loss difference between groups with a standard deviation of 5.8 kg,4,5 a 5% Type I error rate, and 80% power. To adjust for possible clustering effects in this nested design, the adjusted variance estimate was increased to 7.67, calculated using a conservative intraclass correlation coefficient of 0.05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.01
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Class Attendance
Description	Average number of classes attended
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet Only	Internet + Incentives
Arm/Group Description	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.	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: 6 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
Measure Participants	212	206
Mean (Standard Deviation) [Number of classes attended]	16 (6.6)	18 (5.1)

3. Secondary Outcome

Title	Self Monitoring of Body Weight
Description	Number of days with body weight self reported
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet Only	Internet + Incentives
Arm/Group Description	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 app. 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.	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: 6 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
Measure Participants	212	206
Mean (Standard Deviation) [Number of days weight self report]	72 (51)	115 (43)

4. Secondary Outcome

Title	Dietary Intake Self Monitoring
Description	Number of days reported dietary intake over 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet Only	Internet + Incentives
Arm/Group Description	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 app. 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.	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: 6 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
Measure Participants	212	206
Mean (Standard Deviation) [Number of days dietary intake reported]	85 (54)	119 (44)

5. Secondary Outcome

Title	Self Monitoring of Physical Activity
Description	Number of days physical activity reported
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet Only	Internet + Incentives
Arm/Group Description	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 app. 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.	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: 6 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
Measure Participants	212	206
Mean (Standard Deviation) [Number of days Physical Activity report]	85 (54)	118 (44)

6. Secondary Outcome

Title	Steps/Day
Description	Number of Steps/day
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Internet Only	Internet + Incentives
Arm/Group Description	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 app. 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.	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: 6 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
Measure Participants	212	206
Mean (Standard Deviation) [number of steps]	7447 (2888)	8057 (2672)

Adverse Events

Time Frame	Adverse event data were collected from baseline through 6 months. There were no adverse or serious adverse events to report.
Arm/Group Title	Internet Only		Internet + Incentives
Arm/Group Description	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: 6 month behavioral weight loss intervention delivered online		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: 6 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
All Cause Mortality
	Internet Only		Internet + Incentives
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/212 (0%)		0/206 (0%)
Serious Adverse Events
	Internet Only		Internet + Incentives
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/212 (0%)		0/206 (0%)
Other (Not Including Serious) Adverse Events
	Internet Only		Internet + Incentives
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/212 (0%)		0/206 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.