Trial Outcomes & Findings for Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care (NCT NCT00829283)

NCT ID: NCT00829283

Last Updated: 2020-04-03

Results Overview

Binge Remission (abstinence from binge eating)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 191 participants
• Primary outcome timeframe: 12 months follow-up
• Results posted on: 2020-04-03

Participant Flow

Participant milestones

Measure	Standard Care Standard Care Behavioral Weight Loss: weekly individual sessions for 6 months	Stepped-care Stepped-care Behavioral Weight Loss: weekly individual sessions for 6 months Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Placebo: One pill daily Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID
Overall Study STARTED	39	152
Overall Study COMPLETED	32	127
Overall Study NOT COMPLETED	7	25

Reasons for withdrawal

Measure	Standard Care Standard Care Behavioral Weight Loss: weekly individual sessions for 6 months	Stepped-care Stepped-care Behavioral Weight Loss: weekly individual sessions for 6 months Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Placebo: One pill daily Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID
Overall Study Lost to Follow-up	7	25

Baseline Characteristics

Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care

Baseline characteristics by cohort

Measure	Standard Care n=39 Participants Standard Care Behavioral Weight Loss: weekly individual sessions for 6 months	Stepped-care n=152 Participants Stepped-care Behavioral Weight Loss: weekly individual sessions for 6 months Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Placebo: One pill daily Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID	Total n=191 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 9.2 • n=5 Participants	48.0 years STANDARD_DEVIATION 9.6 • n=7 Participants	48.4 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	104 Participants n=7 Participants	136 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	48 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized White	30 participants n=5 Participants	120 participants n=7 Participants	150 participants n=5 Participants
Race/Ethnicity, Customized Black	5 participants n=5 Participants	23 participants n=7 Participants	28 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
BMI	37.5 kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants	39.4 kg/m^2 STANDARD_DEVIATION 6.0 • n=7 Participants	38.9 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months follow-up

Binge Remission (abstinence from binge eating)

Outcome measures

Measure	Standard Care n=39 Participants Standard Care Behavioral Weight Loss: weekly individual sessions for 6 months	Stepped-care n=152 Participants Stepped-care Behavioral Weight Loss: weekly individual sessions for 6 months Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Placebo: One pill daily Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID
Number of Subjects Who Reached Binge Eating Remission	16 participants	65 participants

SECONDARY outcome

Timeframe: 12 months follow-up post-treatment

The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2.

Outcome measures

Measure	Standard Care n=32 Participants Standard Care Behavioral Weight Loss: weekly individual sessions for 6 months	Stepped-care n=127 Participants Stepped-care Behavioral Weight Loss: weekly individual sessions for 6 months Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Placebo: One pill daily Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID
BMI	35.9 kg/m^2 Standard Deviation 6.6	37.1 kg/m^2 Standard Deviation 6.7

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stepped-care

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. Carlos Grilo

Yale School of Medicine

Phone: 203-785-2792

Email: carlos.grilo@yale.edu

Results disclosure agreements

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