Trial Outcomes & Findings for Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study (NCT NCT01435603)
NCT ID: NCT01435603
Last Updated: 2018-04-27
Results Overview
(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
331 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2018-04-27
Participant Flow
Potential participants were prescreened on the phone and attended a baseline visit for further screening and enrollment.
Participant milestones
| Measure |
Standard Lifestyle Advice
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).
Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
|
Advice Plus Lifestyle Intervention
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
Standard Lifestyle Advice: See "Standard Lifestyle Advice" arm.
Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.
|
|---|---|---|
|
Overall Study
STARTED
|
167
|
164
|
|
Overall Study
COMPLETED
|
128
|
129
|
|
Overall Study
NOT COMPLETED
|
39
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study
Baseline characteristics by cohort
| Measure |
Standard Lifestyle Advice
n=167 Participants
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).
Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
|
Advice Plus Lifestyle Intervention
n=164 Participants
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
Standard Lifestyle Advice: See "Standard Lifestyle Advice" arm.
Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.
|
Total
n=331 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
|
124 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
167 participants
n=5 Participants
|
164 participants
n=7 Participants
|
331 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who completed weight measurements at the baseline and 12 month exam
(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.
Outcome measures
| Measure |
Standard Lifestyle Advice
n=128 Participants
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).
Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
|
Advice Plus Lifestyle Intervention
n=129 Participants
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
Standard Lifestyle Advice: See "Standard Lifestyle Advice" arm.
Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.
|
|---|---|---|
|
Percent Change in Body Weight
|
-0.15 percentage of change
Standard Deviation 4.05
|
-1.42 percentage of change
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: 6, 12, and 24 monthsThe study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6,12, and 24 monthsThe study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6, 12, and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6, 12, and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6, 12, and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6, 12, and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6, 12, and 24 monthsOutcome measures
Outcome data not reported
Adverse Events
Standard Lifestyle Advice
Serious events: 10 serious events
Other events: 0 other events
Deaths: 1 deaths
Advice Plus Lifestyle Intervention
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Lifestyle Advice
n=167 participants at risk
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).
Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
|
Advice Plus Lifestyle Intervention
n=164 participants at risk
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
Standard Lifestyle Advice: See "Standard Lifestyle Advice" arm.
Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia (severe: admitted to hospital, emergency room, or needed assistance by other person)
|
2.4%
4/167 • 1 year
|
2.4%
4/164 • 1 year
|
|
Cardiac disorders
Heart attack (myocardial infarction)
|
0.60%
1/167 • 1 year
|
0.61%
1/164 • 1 year
|
|
Cardiac disorders
Congestive Heart Failure
|
0.60%
1/167 • 1 year
|
0.61%
1/164 • 1 year
|
|
Surgical and medical procedures
Balloon angioplasty or Stenting of coronary arteries (Percutaneous transluminal coronary angioplasty
|
1.2%
2/167 • 1 year
|
1.8%
3/164 • 1 year
|
|
Nervous system disorders
Stroke (transient ischemic attack, cerebral ischemia/hemorrhage, or cerebrovascular accident)
|
0.60%
1/167 • 1 year
|
0.61%
1/164 • 1 year
|
|
Cardiac disorders
Cardiac Arryhythmia (atrial fibrillation or flutter)
|
0.00%
0/167 • 1 year
|
0.00%
0/164 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
1.8%
3/167 • 1 year
|
1.2%
2/164 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place