#330

Gaede, Vedel, Hans-Henrik, et al, 1999

Include: type 2 diabetes, albumin excretion rates (AER) of 30-300 mg in a 24-hr urine sample.

Exclude: older than 65 or younger than 40, alcohol abuse, non-diabetic kidney disease, malignancy or life-threatening disease with death probable within 4 years.

RCT- single-center design with 2 groups:
1) Standard (st).
2) Intensified (in).

N=160
n st=80
n in=80

*4 drop-outs in ST (2 withdrew, 2 died), 7 drop-outs in IN (3 withdrew, 4 died)

Age means (SD):
st: 55.2(7.2)
in: 54.9(7.2)

% Female:
st: 30
in: 21.25

Race % not given

Baseline HbA1c % means (SD):
Intended to treat:
st: 8.8 (1.7)
in: 8.4 (1.6)

St and In groups both received individualized diabetic advice. In received additional multifactorial intervention with behavior modification (i.e.,: lowering intake of fat, moderate exercise, spouse-assisted smoking cessation), and stepwise introduction of pharmacological therapy.

4 years with monitoring every 3 months.

Completer Results:

1)Metabolic control:
 a) HbA1c % mean change (SD):
   st: 0.2 (1.9)
   in: -0.8 (1.6)

*Indicated a significant difference between groups (p<0.0001). Statistical test not given.

 b) Fasting glucose (mmol/L) mean change (SD):
   st: -0.3 (4.2)
   in: -2.7 (3.5)

*Indicated a significant difference between groups (p<0.0001). Statistical test not given.

2) Measures of risk:
 a) BMI mean Change (SD):
   st: 0.0 (1.8) men
     0.6 (3.1) women
   in: 1.1 (1.8) men
     1.8 (2.1) women

*ANCOVA indicates significant differences between groups (by sex) in BMI change (men p=0.004; women p=0.06)

 b) Systolic blood pressure mean change (SD):
   st: -4(17)
   in: -8(18)

*Indicated a significant difference between groups (p<0.01). Statistical test not given.

 c) Diastolic blood pressure mean change (SD):
   st: -5 (10)
   in: -7 (10)

*Indicated no significant difference between groups (p=0.21). Statistical test not given.

 d) Currently Smokes Change:
   st: -5
   in: -7

*Indicated no significant difference between groups (p=0.50). Statistical test not given.

 e) Cholesterol mean change (SD):
   st: -15(176)
   in: -79(147)

*Indicated a significant difference between groups (p=0.005). Statistical test not given.

3) Events:
 a) Health care utilization: Not given
 b) Morbidity/mortality:
   st: 2 deaths (cardio- vascular)
   42 total health events
   in: 4 deaths (3 cardio- vascular, 1 cancer)
   26 total health events

*Indicated a significant difference between groups (p=0.03). Statistical test not given.

Quality Assessment:

Internal Validity:

Described as randomized: Yes

Method of randomization clearly described? No

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? No

Outcome assessors blinded? No

No. withdrawals stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? No

Intervention codified in manual? No

Provider training described? No

Patients assessed for DSM dx? No

Biases, etc: Behavior modification not clearly defined/described; statistical methods not clearly explained

#9120

Glasgow, Boles, McKay, Feil, Barrera, 2003

Include: adult type-II diabetes for at least 1 year, are living independently, had a telephone, were literate in English, not planning to move.

Exclude: none given

RCT with 2 groups:
1)Tailored Self Management (TSM) with basic nutrition information.
2) Peer support (PS) with basic nutrition information.
3) Information only (con).

*other groups used in outcome/ results were:
   -no peer support (NPS).
   -no tailored self management (NTSM).

*participants were not randomized into these groups, with grouping system unclear.

N=320

*#'s per group not given

Intended to treat: 18% of pts dropped out before 1-yr f/u

Age mean (SD):
59 (9.2)

53.13% Female

Race %: not given

Baseline HbA1c mean (SD):
7.44 (1.62)

1) Tailored Self-Management—pts work with computer mediated access to a professional "coach" who provides dietary advice to reach their dietary goals negotiated with the online coaches whom they accessed twice a week. The coach suggested strategies to overcome barriers and provide encouragement. Participants could enter information of their daily intake of foods on a personal database. Dietician Q&A conference. Blood glucose and dietary databases and graphical feedback.

2) Peer Support—patients participated in activities, like structured support conferences, where they could interact with one another and discuss diabetes-related information, coping strategies, support concerns, and stressors. Participants could also participate in live chat discussions. Pts. Electronic newsletters (5) containing information on local restaurants that provide low-fat menu options, strategies for talking with doctors, media, and real-life success stories.

3) Information only—pts had computer access to articles on topics of medical, nutritional, and lifestyle aspects of diabetes. They also completed assessments online and received automated dietary change goals. Quarterly online assessments.

10 months, with quarterly online assessments.

Completer Results:

1)Metabolic control:
HbA1c % means (SD):
   NPS: 7.35 (1.56) base
     7.68 (1.10) 10 mo
   PS: 7.54 (1.68) base
     7.42 (1.10) 10 mo
   NTSM: 7.43 (1.71) base
     7.67 (1.10) 10 mo
   TSM: 7.45 (1.53) base
     7.42 (1.10) 10 mo

*MANCOVA reported to be not significant.

2) Measures of risk:
 a) Lipid Ratio:
   NPS: 5.44 (1.79) base
     5.13 (1.16) 10 mo
   PS: 5.43 (1.59) base
     5.02 (1.16) 10 mo
   NTSM: 5.18 (1.44) base
     5.02 (1.17) 10 mo
   TSM: 5.70 (1.89) base
     5.13 (1.16) 10 mo

*MANCOVA reported to be not significant.

3) Events:
 a) Health care utilization: Not given
 b) Morbidity/mortality: Not given

4) Psychological outcomes^d:
 a) CES-D means (SD):
   NPS: 17.8 (10.08) base
     14.06 (9.12) 10 mo
   PS: 18.1 (10.51) base
     12.59 (9.13) 10 mo
   NTSM: 17.9 (10.56) base
     12.93 (9.11) 10 mo
   TSM: 18.0 (10.02) base
     13.72 (9.12) 10 mo

*MANCOVA reported to be not significant.

 b) Total Support Scale means (SD):
   NPS: 4.23 (1.23) base
     4.71 (1.12) 10 mo
   PS: 4.05 (1.28) base
     5.22 (1.11) 10 mo
   NTSM: 4.14 (1.32) base
     4.96 (1.12) 10 mo
   TSM: 4.14 (1.20) base
     4.97 (1.12) 10 mo

*MANCOVA reported to be significant for NPS and PS comparison (p=0.001), but significant for NTSM and TSM comparison.

Quality Assessment:

Internal Validity:

Described as randomized: Yes

Method of randomization clearly described? No

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? No

Outcome assessors blinded? No

No. withdrawals stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? No

Intervention codified in manual? No

Provider training described? No

Patients assessed for DSM dx? No

Biases, etc: Not many measures of risk reported. Actual interventions not explained clearly. Education group never directly compared to intervention groups, group assignment not explained clearly, participant #'s per group not given.

#240

Glasgow & Toobert, 2000

Include: Type II diabetes

Exclude: planning to move within 1 year

2 x 2 RCT:
1)Basic condition (BC).
2) Basic & telephone followup (BCT).
3) Basic & Community Resources (BCC).
4) Combined Condition (CC).

N=320
n BC=80
n BCT=80
n BCC=80
n CC=80

*43 patients did not complete study (BC=13, BCT=13, BCC=5, CC=12)

% Female not given

Race % not given

Baseline HbA1c % means (SD):
Completers:
BC: 7.6 (1.2)
BCT: 7.3 (1.5)
BCC: 7.5 (1.9)
CC: 7.6 (1.8)

Intervention consisted of 3 parts:

1) Interactive multimedia touchscreen assessment of patient's dietary patterns, a tailored fat reduction goal completed at baseline and 3 month followup (BC).

2) Telephone followup (3-4 followup calls before the 6 mo. Followup) to provide support and reinforcement and personalized problem-solving training for barriers on their dietary selfcare (BCT, CC).

3) Community resources were given to participants—newsletters for obtaining support for their eating patterns and goal feedback on ways to decrease setting for community nutrition. Participants had to return a postcard stating which CR they used. A Food-frequency questionnaire was mailed with personally tailored Fat intake (BCC, CC).

Treatment duration not stated. F/u at 3 and 6 mo

Completer Results:

1)Metabolic control
 a) HbA1c % means (SD):
   BC: 7.6 (1.2) base
     7.6 (1.4) 3 mo
     7.4 (1.2) 6 mo
   BCT: 7.3 (1.5) base
     7.3 (1.6) 3 mo
     7.3 (1.4) 6 mo
   BCC: 7.5 (1.9) base
     7.6 (2.1) 3 mo
     7.4 (1.4) 6 mo
   CC: 7.6 (1.8) base
     7.5 (1.7) 3 mo
     7.5 (1.7) 6 mo

*ANCOVA indicated no significant effect of group on HbA1c

2) Measures of risk:
 a) Weight (lbs) means (SD):
   BC: 199 (36) base
     198 (37) 3 mo
     197 (37) 6 mo
   BCT: 212 (49) base
     210 (46) 3 mo
     210 (46) 6 mo
   BCC: 219 (49) base
     217 (47) 3 mo
     217 (48) 6 mo
   CC: 221 (52) base
     218 (49) 3 mo
     219 (51) 6 mo

*ANCOVA indicated no significant effect of group on weight loss.

 b) Total Cholesterol means (SD):
   BC: 210 (40) base
     201 (34) 3 mo
     206 (39) 6 mo
   BCT: 203 (39) base
     202 (34) 3 mo
     194 (30) 6 mo
   BCC: 202 (38) base
     198 (37) 3 mo
     202 (39) 6 mo
   CC: 205 (35) base
     201 (31) 3 mo
     201 (30) 6 mo

*ANCOVA indicated no significant effect of group on Total Cholesterol.

3) Events:
 a) Health care utilization: Not given
 b) Morbidity/mortality: Not given

4) Psychological Measures:
   -Quality of Life: Illness Intrusiveness Scale- IIS means (SD):
   BC: 25.7 (11.1) base
     31.0 (15.6) 3 mo
     26.0 (12.7) 6 mo
   BCT: 29.2 (15.2) base
     30.6 (15) 3 mo
     29.6 (14.9) 6 mo
   BCC: 28.6 (12) base
     32.4 (13) 3 mo
     28.2 (12.4) 6 mo
   CC: 30.8 (15.7) base
     31.4 (13.3) 3 mo
     29.2 (14.0) 6 mo

*ANCOVA indicated no significant effect of group on Quality of Life.

Quality Assessment:

Internal Validity:

Described as randomized? Yes

Method of randomization clearly described? No

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? No

Outcome assessors blinded? No

No. of withdrawals in each group stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? No

Intervention codified in manual? No

Provider training described? No

Patients assessed for DSM dx? No

Biases, etc: Treatment duration not stated

#3090

Glasgow, La Chance, Toobert, Brown, Hampson, Riddle, 1997

Include: type 1 or type 2 diabetes, older than 40 years, being primarily responsible for one's own diabetes dietary self-management

Exclude: not stated

RCT with 2 treatment conditions:
1)Usual Care (con).
2) Brief intervention (int).

N=206
n con=98
n int=108

*33 drop-outs

Age means (SD):
con=63.1(10.5)
int=61.7(12.1)

% Female:
con: 60
int: 63

Baseline HbA1c % means:
Completers:
con: 7.9
int: 7.9

1) Usual care—a high quality quarterly medical care intervention—did not focus on behavioral interventions.

2) 5-10 min touchscreen dietary barriers assessment that generated feedback forms including problem situations to plan for. 20 min patient centered goal setting and problemsolving session, plan to lower fat intake.

2 30 min interventions (1 at time of tx and one at 3 month followup), 6 month phone followup, 12 month followup.

Completer Results:

1)Metabolic control
 a) HbA1c % means:
   con: 7.9 base
     7.8 f/u
   int: 7.9 base
     7.8 f/u

*MANCOVA indicated no significant effect of group on HbA1c at f/u (p=0.42).

2) Measures of risk:
 a) Body Mass Index-BMI means:
   con: 30.2 base
     30.4 f/u
   int: 30.4 base
     30.5 f/u

*MANCOVA indicated no significant effect of group on BMI at f/u (p=0.33).

 b) Serum Cholesterol means (SD):
   con: 223 base
     226 f/u
   int: 217 base
     208 f/u

*MANCOVA indicated a significant effect of group on serum cholesterol at f/u (p=0.002).

3) Events:
 a) Health care utilization: Not given
 b) Morbidity/mortality: Not given

Quality Assessment:

Internal Validity:

Described as randomized? Yes

Method of randomization clearly described? Yes

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? No

Outcome assessors blinded? No

No. of withdrawals in each group stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? Yes

Intervention codified in manual? No

Provider training described? No

Patients assessed for DSM dx? No

Biases, etc: None noted

#3110

Glasgow, Toobert, & Hampson, 1996

Include: Type I or II diabetes; age=40 years; primarily responsible for one's own diabetes self-management

Exclude: None noted

RCT with 2 treatment conditions:
1)Usual Care (con).
2) Brief intervention (int).

N=206
n con=98
n int=108

*26 drop-outs- int: 13; con: 13

Age means (SD):
Intended to treat:
con=63.1(10.5)
int=61.7(12.1)

% Female:
Intended to treat:
con=60
int=63

Race % not given

Baseline HbA1c % means:
Intended to treat:
con: 7.9
int: 7.8

1) Usual care—complete the 15—20 minute computerized assessment, then saw their physician as scheduled and were re-assessed at their scheduled 3 month followup.

2) Intervention—completed one additional touchscreen dietary barriers assessment that generated feedback forms then gave recommendations for personalized strategies to help patients reduce fat intake. Patients were also given a video on frequent barriers (30 min). Patients received followup phone calls at 1 and 3 weeks after the visit. Intervention was repeated 3 months later.

2 separate 20-min sessions and 2 followup phone calls at 1 and 3 weeks.

Completer Results:

1)Metabolic control
 a) HbA1c % means:
   con: 7.9 base
     7.7 f/u
   int: 7.8 base
     7.6 f/u

*ANCOVA indicated no significant effect of group on HbA1c at f/u (p=0.20).

2) Measures of risk:
 a) Serum Cholesterol means:
   con: 223 base
     231 f/u
   int: 216 base
     207 f/u

*ANCOVA indicated a significant effect of group on serum cholesterol at f/u (p=0.0001).

3) Events:
 a) Health care utilization: Not given
 b) Morbidity/mortality: Not given

Quality Assessment:

Internal Validity:

Described as randomized? Yes

Method of randomization clearly described? No

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? No

Outcome assessors blinded? No

No. of withdrawals in each group stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? Yes

Intervention codified in manual? Yes

Provider training described? No

Patients assessed for DSM dx? No

Biases, etc: Not many measures of risk assessed

#6180

Glasgow, Toobert, Hampson, Brown, Lewinsohn & Donnelly, 1992

Include: type II diabetes, age=60 years

Exclude: Positive submaximal exercise test

RCT with 2 treatment conditions:
1)Immediate intervention.
2) Delayed intervention.

N=102
n imm=52
n del=50

*1 subject dropped out before the posttest assessment.

Age means (SD):
imm=67.1(4.3)
del=67.2 (5.8)

% Female:
imm=63.5
del=62.0

Race % not given

Baseline GHb % means (SD):
Completers:
imm: 6.8 (1.6)
del: 7.4 (1.8)

1) Focused on dietary and exercise self-care behaviors and regular blood glucose monitoring. Dietary targets were reducing caloric intake, decreasing consumption of fats and increasing fiber intake. Exercise: regular participation in low level aerobic activity. Also focused on problemsolving and coping strategies.

2) Delayed intervention—received intervention following post-treatment.

8 Weekly meetings followed by 2 biweekly meetings=12 weeks total

Completer Results:

1)Metabolic control
 a) GHb % means (SD):
   imm: 6.8 (1.6) base
     6.3 (1.5) post
     6.7 (1.7) 6 mo
   del: 7.4 (1.8) base
     7.0 (1.5) post
     6.4 (1.4) post replication

*ANCOVA indicated no significant differences between groups.

2) Measures of risk:
   -Weight (lbs) means (SD):
   imm: 188.0 (34.2) base
     182.2 (33.9) post
     186.1 (32.6) 6 mo
   del: 184.5 (34.4) base
     185.9 (34.6) post
     181.0 (34.7) post replication

*ANCOVA indicated no significant differences between groups.

3) Events:
 a) Health care utilization: Not given
 b) Morbidity/mortality: Not given

4) Psychological Measures:
   -Diabetes Quality of Life Scale^e means (SD):
   imm: 37.9 (8.8) base
     38.2 (7.4) post
     38.1 (9.2) 6 mo
   del: 36.8 (8.0) base
     36.3 (8.0) post
     37.2 (7.5) post replication

*paired t-tests indicated no significant differences.

Quality Assessment:

Internal Validity:

Described as randomized? Yes

Method of randomization clearly described? Yes

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? No

Outcome assessors blinded? No

No. of withdrawals in each group stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? Yes

Intervention codified in manual? No

Provider training described? Yes

Patients assessed for DSM dx? No

Biases, etc: Not many measures of risk assessed

#9140

Glasgow, Toobert, Hampson, Stryker, 2002

Include: type II diabetes, lived independently, had a telephone, were not planning to move

Exclude: none noted

RCT with 4 groups:
1)Basic goal setting (BGS).
2) Community Resources (CR).
3) Telephone Followup (TF).
4) Combined Condition (COM).

N=320
n BGS=80
n CR=80
n TF=80
n COM=80

*15 participants withdrew before the 1-yr f/u

Age mean: 59.7

56% Female

Race
(%Caucasian):
BGS=90
CR=90.9
TF=88.6
COM=91.4

Baseline HbA1c mean (SD):
BGS: 7.63 (1.3)
CR: 7.38 (1.6)
TF: 7.55 (1.9)
COM: 7.54 (1.7)

1) Basic Goal Setting—attended baseline assessment with all other participants where completed interactive computer assessment with feedback and brief session with an interventionist. Assessed dietary patterns, barriers, and gave one-page printout summarizing this information. Were given a general pamphlet about low-fat eating.

2) Telephone followup—7 (15-20 min) brief structured calls providing support and reinforcement, personalized problem-solving training.

3) Community Resources—binder of indexed community resources, 8 newsletters focused on identifying opportunities for participants to obtain support for their eating patterns. Goal setting for community support activities was included in each face-to-face meeting.

4) Combined condition received everything mentioned for BGS, TF, and CR.

12 months f/u, 6 months of face-to-face interaction. Visits at BL, 3 and 6 mos. (1-2 hrs)

Completer Results:

1) Metabolic control:
HbA1c % means (SD):
   BGS: 7.63 (1.3) base
     7.43 (1.3) 12 mo
   CR: 7.38 (1.6) base
     6.99 (1.0) 12 mo
   TF: 7.55 (1.9) base
     7.39 (1.3) 12 mo
   COM: 7.54 (1.7) base
     7.23 (1.2) 12 mo

*MANCOVA indicated TF group significantly different than other groups at 12 mo (p<0.05) on all biological measures combined (HbA1c and lipid ratio).

2) Measures of risk:
 a) Lipid Ratio:
   BGS: 5.1 (1.7) base
     4.8 (1.6) 12 mo
   CR: 4.8 (1.4) base
     4.5 (1.2) 12 mo
   TF: 5.2 (3.8) base
     4.3 (1.0) 12 mo
   COM: 4.9 (1.3) base
     4.4 (1.1) 12 mo

3) Event:
 a) Health care utilization: Not given
 b) Morbidity/mortality: Not given

4) Psychological outcomes^d:
 a) Illness Intrusiveness means (SD):
   BGS: 27.1 (14.2) base
     27.8 (12.4) 12 mo
   CR: 28.2 (15.0) base
     32.8 (17.0) 12 mo
   TF: 30.0 (13.6) base
     31.6 (12.7) 12 mo
   COM: 30.8 (15.6) base
     29.5 (12.7) 12 mo

*MANCOVA indicated TF group significantly different than other groups at 12 mo (p<0.05) on all psychological measures combined (illness intrusiveness, illness resources, and self efficacy).

 b) Self Efficacy means (SD):
   BGS: 3.9 (0.8) base
     3.9 (0.7) 12 mo
   CR: 3.9 (0.6) base
     4.1 (0.7) 12 mo
   TF: 3.8 (0.7) base
     4.0 (0.6) 12 mo
   COM: 3.9 (0.6) base
     4.1 (0.7) 12 mo

Quality Assessment:

Internal Validity:

Described as randomized: Yes

Method of randomization clearly described? No

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? No

Outcome assessors blinded? No

No. withdrawals stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? Yes

Intervention codified in manual? No

Provider training described? No

Patients assessed for DSM dx? No

Biases, etc: Statistical analyses not differentiated on measure, but type of outcome (biological, behavioral, or psychosocial)

#6620

Glasgow, Toobert, Mitchell, Donnelly, & Calder, 1989

Include: type II diabetes, GHb >9% or physician judgment of poor control.

Exclude: not stated

RCT with 3 treatment conditions:
1)Nutrition education (NE).
2) Nutrition education + social learning (NE +SL).
3) Wait-list control (WL).

N=78
n NE=20
n NE + SL=23
n WL=16

*4 in NE did not complete study

Age range: 42-75

73% Female

Race % not given

Baseline GHb %:
Intend to treat:
mean=9.7

1) NE—3 targets: reduction in calorie intake, reduction in fat intake, and increases in dietary fiber. Weight loss was deemphasized, but presented as a possible bonus.

2) NE + SL—NE as above, plus other components including goal setting based on individual barriers to adherence and modeling of strategies used successfully by other individuals with type II diabetes, problem solving method called STOP(specify the problem, think of the options, opt for the best solution, put the solution into practice).

3) Wait-list

5 Weekly meetings, 2-month followup

Completer Results:

1)Metabolic control:
 a) GHb % Not given

*Comparisons of groups on GHB said to be not significant. Statistical tests not given.

2) Measures of risk:
 -Not Given

3) Events:
 a) Health care utilization: Not given
 b) Morbidity/mortality: Not given

Quality Assessment:

Internal Validity:

Described as randomized? Yes

Method of randomization clearly described? No

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? No

Outcome assessors blinded? No

No. of withdrawals in each group stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? Yes

Intervention codified in manual? Yes

Provider training described? No

Patients assessed for DSM dx? No

Biases, etc: Results not given for metabolic control; no measures weight, blood pressure, or cholesterol assessed. All 4 drop-outs were in the control (NE) condition.

#3440

Goldhaber-Fiebert, Goldhaber-Feibert, Tristan & Nathan, 2003

Include: Type II diabetes

Exclude: none

RCT with 2 conditions:
1)Control group (con).
2) Intervention Group (int).

N=75
n con=35
n int=40

*14 drop-outs (7 intervention, 7 control)

Age mean (SD):
n con=57(9)
n int=60(10)

% Female:
con=74.3
int=82.5

Race % not given

Baseline GHb% means (SD):
Intention to treat:
con=8.6 (3.9)
int=8.6 (3.7)

1) Control—standard diabetes educational lecture.

2) Intervention—12-week lifestyle intervention (in Spanish), including 11 weekly nutrition classes (90 min) focusing on portion control and healthy food substitutes. Taught of the basic food groups. Subjects set weekly goals for eating behavior changes. Emphasis put on health for all family members. Recorded food diaries. 20 of 40 subjects in this group also participated in a 60-min walking group 3 times a week for 12 weeks.

12 weeks

Completer Results:

1)Metabolic control
 a) GHb % Change means (SD):
   con: -0.4 (2.3) base-post
   int: -1.8 (2.3) base-post

*t-tests indicated significant differences between groups on GHb change (p=0.028)

 b) Fasting Plasma Glucose (mg/dl) Change means (SD):
   con: 16 (78) base-post
   int: -19 (55) base-post

*t-tests indicated significant differences between groups on Fasting Plasma Glucose change (p=0.048)

2) Measures of risk:
 a) Weight (kg) Change means (SD):
   con: 0.4 (2.3) base-post
   int: -1.0 (2.2) base-post

*t-tests indicated significant differences between groups on weight change (p=0.028)

 b) Systolic blood pressure-SBP Change means (SD):
   con: -4 (16) base-post
   int: -5 (23) base-post

*t-tests indicated no significant differences between groups on SBP (p=0.95).

 c) Diastolic blood pressure-DBP Change means (SD):
   con: -3 (8) base-post
   int: -7 (9) base-post

*t-tests indicated no significant differences between groups on DBP (p=0.06).

 d) Total Cholesterol Change means (SD):
   con: 1 (33) base-post
   int: -8 (36) base-post

*t-tests indicated no significant differences between groups on total cholesterol (p=0.31).

 e) HDL Cholesterol Change means (SD):
   con: -3 (6) base-post
   int: -5 (5) base-post

*t-tests indicated no significant differences between groups on HDL-C (p=0.49).

 f) LDL-Cholesterol Change means (SD):
   con: -1 (29) base-post
   int: 5 (36) base-post

*t-tests indicated no significant differences between groups on LDL-C (p=0.53).

3) Events:
 a) Health care utilization: Not given
 b) Morbidity/mortality: Not given

Quality Assessment:

Internal Validity:

Described as randomized? Yes

Method of randomization clearly described? No

Concealment of allocation? No

Described as double-blind? No

Patient blinded? No

Investigators blinded? Yes

Outcome assessors blinded? No

No. of withdrawals in each group stated? Yes

External Validity:

Pop. Described? Yes

Intervention described well enough to reproduce? Yes

Intervention codified in manual? No

Provider training described? Yes

Patients assessed for DSM dx? No

Biases, etc: None noted