Trial Outcomes & Findings for Changing Lifestyles for Better Health (NCT NCT00848757)

NCT ID: NCT00848757

Last Updated: 2022-05-04

Results Overview

The change is weight is reported from baseline to 12 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: Baseline and 12 Months
• Results posted on: 2022-05-04

Participant Flow

Participant milestones

Measure	Intensive Lifestyle Intervention (ILI) Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.	Usual Care Control Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
Overall Study STARTED	65	65
Overall Study COMPLETED	61	61
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Changing Lifestyles for Better Health

Baseline characteristics by cohort

Measure	Intensive Lifestyle Intervention (ILI) n=61 Participants Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.	Usual Care Control n=61 Participants Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.	Total n=122 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	43.0 years STANDARD_DEVIATION 9.7 • n=7 Participants	43 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	61 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	61 participants n=7 Participants	122 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 Months

The change is weight is reported from baseline to 12 months.

Outcome measures

Measure	Intensive Lifestyle Intervention (ILI) n=61 Participants Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.	Usual Care Control n=61 Participants Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
Change in Weight	-3.8 kg Interval -4.6 to -3.0	1.4 kg Interval 0.6 to 2.2

PRIMARY outcome

Timeframe: Baseline and 12 Months

The change in BMI is reported from baseline to 12 months.

Outcome measures

Measure	Intensive Lifestyle Intervention (ILI) n=61 Participants Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.	Usual Care Control n=61 Participants Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
Change in BMI	-1.6 kg/m^2 Interval -2.0 to -1.3	0.6 kg/m^2 Interval 0.2 to 0.9

PRIMARY outcome

Timeframe: Baseline and 12 Months

Change in percent body fat is reported from baseline to 12 months. Body composition by body fat analyzer (TBF-300; Tanita,Arlington Heights, IL) was used.

Outcome measures

Measure	Intensive Lifestyle Intervention (ILI) n=61 Participants Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.	Usual Care Control n=61 Participants Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
Change in Percent Body Fat	-1.9 percent of body fat Interval -2.9 to -1.0	0.4 percent of body fat Interval -0.7 to 1.4

PRIMARY outcome

Timeframe: Baseline and 12 Months

Change in waist circumference was measured from baseline to 12 months

Outcome measures

Measure	Intensive Lifestyle Intervention (ILI) n=61 Participants Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.	Usual Care Control n=61 Participants Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
Change in Waist Circumference	-3.3 cm Interval -5.2 to -1.4	-0.2 cm Interval -2.1 to 1.7

PRIMARY outcome

Timeframe: Baseline and 12 Months

Change in blood pressure was measured from baseline to 12 months

Outcome measures

Measure	Intensive Lifestyle Intervention (ILI) n=61 Participants Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.	Usual Care Control n=61 Participants Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.
Change in Blood Pressure Systolic blood pressure	-1.5 mm Hg Interval -5.0 to 2.1	0 mm Hg Interval -3.6 to 3.6
Change in Blood Pressure Diastolic blood pressure	-0.5 mm Hg Interval -2.8 to 1.7	-0.9 mm Hg Interval -3.2 to 1.4

SECONDARY outcome

Timeframe: 12 months

Population: Data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Usual Care Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intensive Lifestyle Intervention (ILI)

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

Michelle Van Name

Yale University School of Medicine

Phone: 203-785-5831

Email: michelle.vanname@yale.edu

Results disclosure agreements

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