Trial Outcomes & Findings for A Lifestyle Change Program to Prevent Type 2 Diabetes (NCT NCT00886340)

NCT ID: NCT00886340

Last Updated: 2012-05-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2012-05-07

Participant Flow

Participant milestones

Measure	Enhanced Standard Care Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)	Lifestyle Counseling Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
Overall Study STARTED	27	31
Overall Study COMPLETED	27	24
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Measure	Enhanced Standard Care Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)	Lifestyle Counseling Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
Overall Study Withdrawal by Subject	0	7

Baseline Characteristics

A Lifestyle Change Program to Prevent Type 2 Diabetes

Baseline characteristics by cohort

Measure	Enhanced Standard Care n=27 Participants Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)	Lifestyle Counseling n=31 Participants Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)	Total n=58 Participants Total of all reporting groups
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	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	43.2 years STANDARD_DEVIATION 13.2 • n=5 Participants	48.2 years STANDARD_DEVIATION 12.4 • n=7 Participants	45.7 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Enhanced Standard Care n=27 Participants Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)	Lifestyle Counseling n=24 Participants Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss	3 participants	6 participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

Enhanced Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lifestyle Counseling

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

Robin Whittemore, PhD

Yale School of Nursing

Phone: 203-737-2351

Email: robin.whittemore@yale.edu

Results disclosure agreements

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