Trial Outcomes & Findings for Evaluation of Group Lifestyle Balance Maintenance Strategies (NCT NCT00869609)
NCT ID: NCT00869609
Last Updated: 2016-06-24
Results Overview
Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Results posted on
2016-06-24
Participant Flow
The project was implemented in two settings: the first within an urban University campus and the second at a suburban YMCA. Recruitment commenced in May 2009 and was completed in July 2009.
Participant milestones
| Measure |
GLB Traditional Maintenance (TM)
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Group Lifestyle Balance Maintenance Strategies
Baseline characteristics by cohort
| Measure |
GLB Traditional Maintenance (TM)
n=31 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=29 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Intention to treat analyses were performed; for those with missing weights at the post-intervention, 8 and 12 month visits, the last documented observation was carried forward. This information was available from the session data, where weight was collected weekly.
Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=31 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=29 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in Weight
|
2.1 pounds
Standard Deviation 5.9
|
0.2 pounds
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with medication changes relevant to the outcome were excluded.
Total cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=27 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=28 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in Total Cholesterol
|
8.6 mg/dl
Standard Deviation 23.2
|
15.4 mg/dl
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with medication changes relevant to the outcome were excluded.
High-density lipoprotein (HDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=27 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=28 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in HDL Cholesterol
|
2.9 mg/dl
Standard Deviation 7.0
|
5.1 mg/dl
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with medication changes relevant to the outcome were excluded.
Low-density lipoprotein (LDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=27 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=27 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in LDL Cholesterol
|
5.2 mg/dl
Standard Deviation 20.0
|
5.8 mg/dl
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with relevant medication changes were excluded.
Triglycerides were measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=27 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=27 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in Triglycerides
|
-0.003 mg/dl
Standard Deviation 0.22
|
-0.006 mg/dl
Standard Deviation 39
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with relevant medication changes were excluded.
Fasting plasma glucose was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=31 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=27 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
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|---|---|---|
|
Change in Fasting Glucose
|
1.2 mg/dl
Standard Deviation 4.7
|
0.2 mg/dl
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with relevant medication changes were excluded.
Collected via venous blood draw, the HbA1c level reflects glucose concentration over the previous period (approximately 8-12 weeks, depending on the individual) and provides an indication of long-term glycemic control.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=31 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=28 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in Glycosylated Hemoglobin A1c (HbA1c)
|
-0.06 percentage of glycosylated hemoglobin
Standard Deviation 0.18
|
-0.08 percentage of glycosylated hemoglobin
Standard Deviation .18
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with relevant medication changes were excluded.
Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=27 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=24 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-0.43 mmHg
Standard Deviation 10.5
|
-3.6 mmHg
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with relevant medication changes were excluded.
Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=27 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=24 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-2.1 mmHg
Standard Deviation 7.0
|
-3.2 mmHg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Measured at 8 months post intervention and 4 months post-randomization to maintenance groupPopulation: Participants with relevant medication changes were excluded.
Waist circumference was measured at the midpoint between the lower rib margin and the iliac crest; the measurement was repeated twice and the average computed.
Outcome measures
| Measure |
GLB Traditional Maintenance (TM)
n=31 Participants
Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
GLB-Carb-focused Maintenance (CF)
n=29 Participants
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
|
|---|---|---|
|
Change in Waist Circumference
|
-0.4 inches
Standard Deviation 1.3
|
-0.2 inches
Standard Deviation 1.4
|
Adverse Events
GLB Traditional Maintenance (TM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GLB-Carb-focused Maintenance (CF)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place