Trial Outcomes & Findings for Maintenance-Tailored Obesity Treatment (NCT NCT00670462)

NCT ID: NCT00670462

Last Updated: 2017-03-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 213 participants
• Primary outcome timeframe: Baseline to18 months
• Results posted on: 2017-03-22

Participant Flow

Participant milestones

Measure	Standard Behavioral Treatment (SBT) Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Overall Study STARTED	106	107
Overall Study COMPLETED	76	76
Overall Study NOT COMPLETED	30	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maintenance-Tailored Obesity Treatment

Baseline characteristics by cohort

Measure	Standard Behavioral Treatment (SBT) n=106 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=107 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B	Total n=213 Participants Total of all reporting groups
Region of Enrollment United States	106 participants n=5 Participants	107 participants n=7 Participants	213 participants n=5 Participants
energy intake (kcal/day)	1980.4 kcal/day STANDARD_DEVIATION 924.7 • n=5 Participants	1976.4 kcal/day STANDARD_DEVIATION 922.7 • n=7 Participants	1978.4 kcal/day STANDARD_DEVIATION 921.5 • n=5 Participants
energy expenditure (kcal/wk)	884.2 kcal/wk STANDARD_DEVIATION 958.7 • n=5 Participants	954.2 kcal/wk STANDARD_DEVIATION 1267.2 • n=7 Participants	919.2 kcal/wk STANDARD_DEVIATION 1112.95 • n=5 Participants
BMI (kg/m2)	35.2 kg/m2 STANDARD_DEVIATION 2.8 • n=5 Participants	34.6 kg/m2 STANDARD_DEVIATION 2.8 • n=7 Participants	34.9 kg/m2 STANDARD_DEVIATION 2.8 • n=5 Participants
Age, Continuous	49.1 years STANDARD_DEVIATION 10.6 • n=5 Participants	48.5 years STANDARD_DEVIATION 10.5 • n=7 Participants	48.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	102 Participants n=5 Participants	103 Participants n=7 Participants	205 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	58 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	49 Participants n=7 Participants	100 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 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	21 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	69 Participants n=7 Participants	143 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to18 months

Population: Waist-to-hip Ratio" was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized.

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=106 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=107 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Change in Body Weight	9.3 kg Standard Deviation 8.8	8.3 kg Standard Deviation 8.9

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Waist-to-hip Ratio" was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized.

change from baseline in energy expenditure at 6 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=98 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=101 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Physical Activity, Energy Expenditure	964.1 kcal/wk Standard Error 131.8	726.4 kcal/wk Standard Error 128.2

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Waist-to-hip Ratio" was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized.

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=98 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=101 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Change From Baseline in Energy Intake at 6 Months	-491.2 kcal/day Standard Error 72.6	-576.4 kcal/day Standard Error 71.1

SECONDARY outcome

Timeframe: baseline, 6, 12, 18, and 30 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=113 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=100 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Waist-to-hip Ratio at Baseline	.85 ratio Standard Error .01	.99 ratio Standard Error .01

SECONDARY outcome

Timeframe: baseline, 6, 12, 18, and 30 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 6, 12, 18, and 30 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 6, 12, 18, and 30 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 6, 12, 18, and 30 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 6, 12, 18, and 30 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

change from baseline in energy expenditure at 12 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=85 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=94 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Physical Activity, Energy Expenditure	814.8 kcal/wk Standard Error 141.0	554.6 kcal/wk Standard Error 134.9

SECONDARY outcome

Timeframe: 18 months

change from baseline in energy expenditure at 18 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=77 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=81 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Physical Activity, Energy Expenditure	856.3 kcal/wk Standard Error 177.6	356.0 kcal/wk Standard Error 189.9

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=85 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=94 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Change From Baseline in Energy Intake at 12months	-544.1 kcal/day Standard Error 80.7	-538.2 kcal/day Standard Error 78.2

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=77 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=81 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Change From Baseline in Energy Intake at 18 Months	-326.3 kcal/day Standard Error 128.7	-490.1 kcal/day Standard Error 134.0

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=113 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=100 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Waist-to-hip Ratio at 6 Months	.84 ratio Standard Error .01	.96 ratio Standard Error .01

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=113 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=100 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Waist-to-hip Ratio at 12 Months	.83 ratio Standard Error .01	.95 ratio Standard Error .01

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=113 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=100 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Waist-to-hip Ratio at 18 Months	.83 ratio Standard Error .01	.96 ratio Standard Error .01

SECONDARY outcome

Timeframe: 30 months

Outcome measures

Measure	Standard Behavioral Treatment (SBT) n=113 Participants Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=100 Participants Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Waist-to-hip Ratio at 30 Months	.85 ratio Standard Error .01	.97 ratio Standard Error .01

Adverse Events

Standard Behavioral Treatment (SBT)

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Maintenance-Tailored Treatment (MTT)

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Behavioral Treatment (SBT) n=106 participants at risk Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=107 participants at risk Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Cardiac disorders heart attack death	0.00% 0/106	0.93% 1/107 • Number of events 1

Other adverse events

Measure	Standard Behavioral Treatment (SBT) n=106 participants at risk Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training.	Maintenance-Tailored Treatment (MTT) n=107 participants at risk Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B
Cardiac disorders cardiac events	3.8% 4/106 • Number of events 4	2.8% 3/107 • Number of events 3
Skin and subcutaneous tissue disorders Skin event	0.00% 0/106	0.93% 1/107 • Number of events 1
Musculoskeletal and connective tissue disorders musculoskeletal events	11.3% 12/106 • Number of events 12	12.1% 13/107 • Number of events 13
Surgical and medical procedures surgical events	2.8% 3/106 • Number of events 3	2.8% 3/107 • Number of events 3
Ear and labyrinth disorders ear event	0.00% 0/106	0.93% 1/107 • Number of events 1
Gastrointestinal disorders gastrointestinal events	0.94% 1/106 • Number of events 1	1.9% 2/107 • Number of events 2
Endocrine disorders endocrine events	0.94% 1/106 • Number of events 1	0.00% 0/107
Pregnancy, puerperium and perinatal conditions pregnancies	2.8% 3/106 • Number of events 3	0.00% 0/107
Reproductive system and breast disorders reproductive events	0.94% 1/106 • Number of events 1	0.93% 1/107 • Number of events 1
Infections and infestations infection	0.94% 1/106 • Number of events 1	0.00% 0/107
Renal and urinary disorders renal event	0.94% 1/106 • Number of events 1	0.93% 1/107 • Number of events 1
Eye disorders eye events	0.94% 1/106 • Number of events 1	0.93% 1/107 • Number of events 1
Skin and subcutaneous tissue disorders skin event	0.94% 1/106 • Number of events 1	0.00% 0/107

Additional Information

Robert W. Jeffery PhD

University of Minnesota

Phone: 612-626-8580

Email: jeffe001@umn.edu

Results disclosure agreements

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