Trial Outcomes & Findings for Considering Patient Diet Preferences to Optimize Weight Loss (NCT NCT01152359)
NCT ID: NCT01152359
Last Updated: 2019-04-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
207 participants
Primary outcome timeframe
Baseline, 48 weeks
Results posted on
2019-04-12
Participant Flow
Participant milestones
| Measure |
Choice Arm
Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
Control Arm
Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
102
|
|
Overall Study
COMPLETED
|
81
|
80
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Considering Patient Diet Preferences to Optimize Weight Loss
Baseline characteristics by cohort
| Measure |
Choice Arm
n=105 Participants
Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
Control Arm
n=102 Participants
Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 11 • n=99 Participants
|
55 years
STANDARD_DEVIATION 10 • n=107 Participants
|
55 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
152 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=99 Participants
|
102 participants
n=107 Participants
|
207 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 48 weeksOutcome measures
| Measure |
Choice Arm
n=105 Participants
Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
Control Arm
n=102 Participants
Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
|---|---|---|
|
Percent Change in Body Weight From Baseline to 48 Weeks
|
-4.2 percentage of weight change
Interval -5.0 to -3.4
|
-5.3 percentage of weight change
Interval -6.1 to -4.4
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Choice Arm
n=105 Participants
Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
Control Arm
n=102 Participants
Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
|---|---|---|
|
Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)
|
9.4 percentage of deviation from goal
Interval 6.6 to 12.3
|
10.3 percentage of deviation from goal
Interval 7.5 to 13.1
|
SECONDARY outcome
Timeframe: Baseline, 48 weekschange in obesity-specific health-related quality of life as measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire total score from baseline to 48 weeks Minimum 0 Maximum 100 Higher score means better
Outcome measures
| Measure |
Choice Arm
n=105 Participants
Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
Control Arm
n=102 Participants
Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
|---|---|---|
|
Change in Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire From Baseline to 48 Weeks
|
10.5 score on a scale
Interval 8.0 to 12.9
|
11.2 score on a scale
Interval 8.8 to 13.6
|
Adverse Events
Control Arm
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Choice Arm
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Arm
n=102 participants at risk
Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
Choice Arm
n=105 participants at risk
Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
|---|---|---|
|
Cardiac disorders
CHF
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
hip surgery
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
spine surgery
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
diverticulitis
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Hepatobiliary disorders
gallbladder surgery
|
0.98%
1/102 • Number of events 1
|
0.00%
0/105
|
|
Skin and subcutaneous tissue disorders
finger infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/105
|
|
Skin and subcutaneous tissue disorders
snake bite
|
0.98%
1/102 • Number of events 1
|
0.00%
0/105
|
|
Cardiac disorders
chest pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/105
|
Other adverse events
| Measure |
Control Arm
n=102 participants at risk
Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
Choice Arm
n=105 participants at risk
Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
|
|---|---|---|
|
Vascular disorders
Elevated blood pressure
|
2.9%
3/102 • Number of events 3
|
7.6%
8/105 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
broken hand
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
lumps in hand
|
0.00%
0/102
|
0.95%
1/105 • Number of events 2
|
|
Vascular disorders
presyncope
|
2.0%
2/102 • Number of events 2
|
0.95%
1/105 • Number of events 1
|
|
Immune system disorders
angioedema
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Ear and labyrinth disorders
inner ear infection
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Endocrine disorders
hypoglcyemia
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
kidney stone
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
sciatica
|
0.98%
1/102 • Number of events 1
|
0.00%
0/105
|
|
Musculoskeletal and connective tissue disorders
motor vehicle collision
|
0.98%
1/102 • Number of events 1
|
0.00%
0/105
|
|
Nervous system disorders
paresthesia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/105
|
|
Gastrointestinal disorders
heartburn
|
0.98%
1/102 • Number of events 3
|
0.00%
0/105
|
|
Nervous system disorders
dysphonia/vocal cord disorder
|
0.98%
1/102 • Number of events 1
|
0.00%
0/105
|
|
Nervous system disorders
carpal tunnel syndrome
|
0.00%
0/102
|
0.95%
1/105 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place