#5220

Agurs-Collins, Kumanyika, Ten Have & Adams-Campbell, 1997

Include: African-American, diagnosed NIDDM,=55 years old,=120% of Metropolitan weight standards, HbA1c=8%

Exclude: nonambulatory, medical contraindications to program participation

RCT with 2 treatment conditions:

1) Usual care.
2) Intervention.

N=64
n uc=32
n int=32

*9 did not complete the program (7 from control, 2 from intervention).

Age means (SD):
uc=61(5.7)
int=62.4(5.9)

Age range: 55-79

% Female:
uc: 88
int: 66

Race % not given

Baseline HbA1c means (SD):
Intention to treat:
uc: 10.0 (1.9)
int: 11.0 (1.7)

1) Usual care.

2) Intervention—program was age and culture appropriate for pop. Encouraged adherence to a healthy diet, moderate physical activity at least 3 times a week. In the first 3 months, 12 weekly group sessions were held for an hour with a 30 min discussion on nutrition education and then a 30 min exercise session in the physical therapy area of the clinic. One individual diet counseling session during this pd. The next 3 months consisted of 6 bi-weekly (90 min) group sessions providing additional information and support, with sharing, problem solving. Each participant also received an individualized weight reduction diet. The behavioral component included topics such as relapse prevention and weight maintenance, goal setting, controlling triggers to eat and portion control. Participants were asked to keep food and exercise diaries. Spouses were encouraged to come to the interventions as well.

6 months. Assessments made at 0, 3, and 6 mos.

Completer Results:

1) Metabolic control:
 a) HbA1c % means (SD):
   uc: 10.0 (1.9) base
     10.3 (1.9) 3 mo
     11.5 (4.4) 6 mo
   int: 11.0 (1.7) base
     9.5 (1.8) 3 mo
     9.9 (2.0) 6 mo

*Reported a significant between group difference in HbA1c at 3- and 6-months (p<0.01). Statistical test not given.

2) Measures of risk:
 a) Weight (kg) means (SD):
   uc: 94.9 (20.1) base
     96.2 (21.2) 3 mo
     96.9 (21.6) 6 mo
   int: 93.3 (18.6) base
     90.8 (20.3) 3 mo
     90.7 (20.1) 6 mo

*Reported a significant between group difference in weight at 3- and 6-months (p<0.01). Statistical test not given.

 b) Systolic blood pressure-SBP means (SD):
   uc: 139 (14) base
     148 (24) 3 mo
     147 (22) 6 mo
   int: 144 (17) base
     144 (21) 3 mo
     146 (21) 6 mo

*Reported no significant differences in SBP between groups at 3 and 6 mo. Statistical test not given.

 c) Diastolic blood pressure-DBP means (SD):
   uc: 77 (10) base
     79 (8) 3 mo
     80 (10) 6 mo
   int: 79 (10) base
   78 (10) 3 mo
   79 (9) 6 mo

*Reported no significant differences in DBP between groups at 3 and 6 mo. Statistical test not given. (p<0.05 at 6-months)

 d) HDL Cholesterol means (SD):
   uc: 52.6 (15) base
     50.9 (12.9) 3 mo
     51.9 (14.2) 6 mo
   int: 49.2 (9.9) base
     46.1 (8.1) 3 mo
     46.8 (10.8) 6 mo

*Reported no significant decrease in HDL for both groups at 3 and 6 mo. Statistical test not given.

 e) LDL Cholesterol means (SD):
   uc: 156.0 (47.9) base
     150.1 (27.8) 3 mo
     154.6 (30.7) 6 mo
   int: 171.9 (37) base
     156.1 (32.8) 3 mo
     162.4 (39.2) 6 mo

*Reported no significant decrease in LDL for both groups at 3 and 6 mo. Statistical test not given.

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? Yes

Provider training described? Yes

Patients assessed for DSM dx? No

Biases, etc: None Noted

#460

Aikens, Kiolbasa, Sobel, 1997

Include: NIDDM=1 year

Exclude: comorbid medical conditions affecting metabolic or neuroendocrine function; gross medical noncompliance

RCT- single-center design with 2 groups:
1) Control.
2) Relaxation training (tx).

N=22
n control=10
n tx=12

*No drop-outs

Age mean (SD): 61 (10.2)

Age range=33-83

59% Female

Race %:
59-African Amer.
32-Caucasian
5-Hispanic
5-Asian

Baseline GHb % means (SD):
Completers:
control: 12.0 (1.7)
tx: 10.2 (1.9)

Relaxation group attended group sessions consisting of:
1) Rationale for the practice of relaxation.
2) General guidelines for encouraging relaxation and discussion of role of stress.
3) In-session therapist-guided instruction emphasizing progressive muscle relaxation.
4) Brief relaxing imagery component.

8-week intervention with followup at week 16 (f/u).

Completer Results:

1) Metabolic control:
 a) GHb % means (SD):
   control: 12.0 (1.7) base
     11.3 (1.7) f/u
   tx: 10.2 (1.9) base
     10.2 (1.6) f/u

*ANCOVA indicated no significant effect of group on Week 16GHb.

 b) Area under 2-hour oral- glucose-tolerance curve (AUC) means (SD):
   control: 32,110 (9,002) base
     33,965 (8,212) post
     32,167 (7,212) f/u
   tx: 33,493 (7,335) base
     35,271 (6,286) post
     35,408 (7,008) f/u

*ANOVA indicated no significant effect of group on Post and Week 16 AUC

2) Measures of risk: Not given

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

4) Psychological Measures:
 a) Generalized distress (General Severity Index-GSI^a) means (SD):
   con: 53.8 (11) base
     55.6 (8.7) post
     56.1(7.9) f/u
   tx: 57.5 (10) base
     51.4 (8.9) post
     54.1 (12) f/u

*Significance not given

 b) Anxiety Symptoms (Symptoms Checklist-90 Revised-SCL-90R^a) means (SD):
   con: 46.6 (13.3) base
     50.0 (11.2) post
     52.1(11.1) f/u
   tx: 52.5 (11.9) base
     47.4 (8) post
     49.8 (13.5) f/u

*Significance not given

c) Daily Stress (Daily Hassles^a) means (SD):
   con: 24.3 (13.3) base
     28.3 (16) post
     29 (11) f/u
   tx: 37.4(18.8) base
     29.5(15.1) post
     28.4(15.8) f/u

*Significance 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

Investigators blinded? No

Outcome assessors blinded? No

No. withdrawals stated? Yes, none.

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: Investigators state that baseline GHb significantly different between groups, but did not use baseline measures as covariate; very small sample.

#2920

Anderson, Funnell, Butler, Arnold, Fitzgerald, & Feste, 1995

Include: type II diabetes

Exclude: not stated

RCT with 2 treatment conditions:
1) Intervention group (int).
2) Wait-list control group (wl).

N=64

*18 subjects were not randomized, 10 subjects dropped out (does not specify from which groups).

Age mean: 50

% Female: 70

Race % not given

Baseline GHb % means (sd):
Completers:
int: 11.75 (3.01) wl: 10.82 (2.94)

1) Intervention—6 weekly session patient empowerment education program: designed to enhance the ability of patients to identify and set realistic goals, to apply problemsolving processes to eliminated barriers, help cope with circumstances that cannot be changed, manage the stress caused by living with diabetes, obtain social support, and improve self-motivation.

2) Wait-list control—after the first six weeks, the control group completed the six-session empowerment program.

6-weeks, followup completed by both groups after 12-weeks.

Completer Results:

1) Metabolic control
 a) GHb % means (SD):
   int: 11.75 (3.01) base
     11.02 (2.89) post
   wl: 10.82 (2.94) base
     10.78 (2.59) post

*t-tests indicated a significantly greater reduction in int group compared to wl (p=0.05).

2) Measures of risk: Not given

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

4) Psychological Measures:
 a) Self Efficacy mean Change Scores^b:
   -Assessing satisfaction:
     int: 0.29 base-post
     wl: -0.04 base-post

*t-tests indicated no significant difference. Statistical test not given.

-Setting goals:
     int: 0.69 base-post
     wl: -0.12 base-post

*t-tests indicated a significant difference (p<0.001). Statistical test not given.

   -Solving problems:
     int: 0.32 base-post
     wl: -0.02 base-post

*t-tests indicated no significant difference. Statistical test not given.

   -Emotional coping:
     int: 0.41 base-post
     wl: 0.12 base-post

*Analysis indicated no significant difference. Statistical test not given.

   -Managing stress:
     int: 0.29 base-post
     wl: 0.01 base-post

*Analysis indicated a significant difference (p=0.05). Statistical test not given.

   -Obtaining support:
     int: 0.36 base-post
     wl: -0.11 base-post

*Analysis indicated a significant difference (p=0.002). Statistical test not given.

   -Motivating oneself:
     int: 0.29 base-post
     wl: -0.09 base-post

*Analysis indicated no significant difference. Statistical test not given.

   -Making decisions:
     int: 0.47 base-post
     wl: 0.05 base-post

*Analysis indicated a significant difference (p=0.02). 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. 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: No measures of risk assessed; no statistical analyses reported.

#840

Boehm, Schlenk, Raleigh, Ronis, 1993

Include: Under physician care for Type II Diabetes, Age =18 years

Exclude: non-English literate

RCT-multi center design with 4 groups:
1) Attention control (attention).
2) Compliance.
3) Behavioral strategies (beh. strat.).
4) Behavioral strategies with instruction (beh. strat. w/ inst.).

N=156
n attention=41
n compliance=32
n beh.strat.=42
n beh.strat w/inst.=41

*does not state # of drop-outs

mean age (SD): 58 (11.3)

60% Female

Race % not given

Baseline GHb %: Not given

1) Attention—received routine care & consistent followup by clinical nurse.

2) Compliance—focused on behaviors directly related to regimen.

3) Beh. strat.—behavioral analyses sessions with nurse that focused on one of 4 strategies: self-monitoring, stimulus control, changing behaviors in small steps and self-resourcefulness.

4) Beh. strat. w/ inst.—behavioral analyses with nurse & received instruction about strategies and behavioral analysis.

Ranged from 1.5-29 months. mean treatment period=12.8 months

Completer Results:

1) Metabolic control: GHb (% change mean (SD)):
   attention: -4.98 (26.08)
   compliance: -5.02 (20.37)
   beh. strat.: 1.73 (20.27)
   beh. strat. w/inst.: 1.6 (25.93)

*t-tests indicated no significant between-group differences

2) Measures of risk: Weight (% change mean (SD)):
   attention: 1.3 (6.97)
   compliance: 0.47 (6.08)
   beh. strat.: -1.52 (6.89)
   beh. strat. w/inst.: 1.54(8.71)

*t-tests indicated no significant between-group differences

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. withdrawals stated? No

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: Large range in treatment duration

#3830

Brown, Garcia, Kouzekanani & Hanis, 2002

Include: type II diabetes, 35-70 years old

Exclude: pregnant women, medical contraindications

*recruited from Mexican-American community in Texas.

RCT with 2 treatment conditions:
1) Experimental (exp).
2) 1-yr. Wait-listed control group receiving usual care (wl).

N=256
n exp=126
n wl=126

*4 patients did not complete study

Age means (SD):
n exp=54.7(8.2)
n wl=53.3 (8.3)

Age range: 35-71

% Female:
exp=60
wl=68

Race % not given

Baseline HbA1c % means (SD):
exp : 11.81 (3)
wl : 11.8 (3.02)

1) 1-yr wait list condition has usual care.

2) Intervention—employed bilingual Mexican American nurses/dietitians. Focused on realistic health recommendations and showed videos of community leaders discussing their experiences with diabetes. Focused on improving blood glucose levels rather than on weight loss: provided rapid, frequent feedback; promoted group problem-solving; involved support from family and friends. Taught self-monitoring of blood glucose, exercise, problem-solving and food preparation demonstrations.

52 contact hours, over 12 months. Longitudinal followup for up to 3 years

1) Metabolic control:
 a) HbA1c % means (SD):
   exp: 11.81 (3.0) base
     10.6 (2.64) 3 mo
     10.8 (2.8) 6 mo
     10.89 (2.56) 12 mo
   wl: 11.80 (3.02) base
     11.22 (2.77) 3 mo
     12.2 (2.95) 6 mo 11.64 (2.85) 12 mo

*ANCOVA indicated significant effect of group on HbA1c at 6 mo (p<0.001) and 12 mo (p=0.011)

 b) Fasting Blood Glucose-FBG means (SD):
   exp: 213.01 (64.06) base
     189.62 (66.97) 3 mo
     185.24 (60.90) 6 mo
     194.95 (63.27) 12 mo
   wl: 207.12 (71.41) base
     201.01 (62.16) 3 mo
     215.04 (66.81) 6 mo
     210.51 (66.55) 12 mo

*ANCOVA indicated significant effect of group on FBG at 3 mo (p=0.038), 6 mo (p<0.001) and 12 mo (p=0.019)

2) Measures of risk:
 a) BMI means (SD):
   exp: 32.33 (5.97) base
     31.9 (6.05) 3 mo
     31.7 (5.84) 6 mo
     32.17 (6.45) 12 mo
   wl: 32.12 (6.35) base
     32.73 (6.84) 3 mo
     32.47 (6.83) 6 mo
     32.28 (6.52) 12 mo

*ANCOVA indicated no significant effect of group on BMI.

 b) Cholesterol means (SD):
   exp: 211.83 (45.34) base
     191.39 (41.12) 3 mo
     192.46 (40.34) 6 mo
     189.88 (36.35) 12 mo
   wl: 203.57 (6.35) base
     187.93 (40.84) 3 mo
     185.88 (40.53) 6 mo
     187.64 (42.66) 12 mo

*ANCOVA indicated no significant effect of group on Cholesterol at 3, 6 and 12 mo.

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? No

Provider training described? Yes

Patients assessed for DSM dx? No

Biases, etc: F/u continued for 3 years, yet did not report any longitudinal findings beyond one year.

# 1440

Cabrera-Pivaral, Gondalez-Perez, Vega-Lopez, et al 2000

Include: Type II diabetes

Exclude: Insulin treatment

RCT with 2 groups:
1) Diabetes education (con).
2) Behavior modification (tx).

N=49
n con=24
n tx=25

Age means (SD):
con: 57.8 (8.7)
tx: 58.1 (12.4)

% Female:
con: 54.2
tx: 48

Race % not given

Baseline Glucose (mg/dl) means(SD): Completers:
con: 221 (83)
tx: 210 (43)

Behavior modifying program consisted of the development of the patients' natural skills and abilities, encouraging communication and the exchange of ideas, and the use of various participation techniques. Program focused on changing thoughts, behaviors and feelings. Educational control patients received information about nutrients, calories, and metabolic control.

Weekly sessions over 9 mo. period.

Completer Results:

1) Metabolic control:
 -Glucose (mg/dl) means (SD):
   con: 221 (83) base
     182 (48) final 3 mos. mean
   tx: 210 (43) base
     147 (32) final 3 mos. mean

*Between group differences not given. Statistical test not given.

2) Measures of risk:
 -Total Cholesterol means (SD):
   con: 225 (39) base
     222 (27) final 3 mos. mean
   tx: 230 (41) base
     199 (21) final 3 mos. mean*

*Between group differences not given. Statistical test 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? No

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 clearly explained; between-group results not reported

#620

Campbell, Redman, Moffitt, et al. 1996

Include: diagnosed with NIDDM <5 years; age<80

Exclude: previous formal instruction in diabetes care; taking over 75% of maximum oral hypoglycemic dosage; terminal illness diagnosis

RCT-single-center design with 4 groups:
1) Minimal(min).
2) Individual education (ind).
3) Group education (grp).
4) Behavioral (beh).

N=238
n min=59
n ind=57
n grp=66
n beh=56

*56 patients did not complete study—ind: 23; grp: 28; beh: 5

Age means (SD):
min=58.2 (1.3)
ind=56.8 (1.5)
gr=58.4 (1.4)
beh=60.9 (1.4)

% Female:
min=63
ind=42
grp=47
beh=57

Race % not given

Baseline HbA1 means (SD):
Intended to treat:
min=11.9 (0.6)
ind=12.2 (0.5)
grp=12.1 (0.6)
beh=13.3 (0.6)

1) Min-2 sessions: received minimal information about diet, exercise & diabetic education.

2) Ind—individual sessions plus 3 day small group course: focused on diet, exercise & diabetic education.

3) Grp—group education sessions with information about diet, exercise & diabetic education.

4) Beh—nurse-taught cognitive-behavioral strategies focused on eating, exercise & smoking in individual visits=3.

Ranged from 2 weeks to 12 months.

Completer Results:

1) Metabolic control:
HbA1 (% change mean (SD)):
   min=-3.5 (0.6) 3 mo
     -2.2 (0.8) 6 mo
   ind=-3.4 (0.7) 3 mo
     -3.9 (0.6) 6 mo
     -3.3 (0.9) 12 mo
   grp=-3.8 (0.6) 3 mo
     -5 (0.9) 6 mo
     -3 (1.1) 12 mo
   beh=-4.7 (0.6) 3 mo
     -4.7 (0.7) 6 mo
     -4.8 (0.7) 12 mo

*ANCOVA indicated no significant effect of group on HbA1c at 6 mo and 12 mo

2) Measures of risk:
 a) BMI (% change mean (SD)):
   min=-1.8 (0.3) 3 mo
     -1.4 (0.4) 6 mo
   ind=-1.9 (0.2) 3 mo
     -2.2 (0.3) 6 mo
     -2 (0.4) 12 mo
   grp=-1.6 (0.2) 3 mo
     -2.2 (0.3) 6 mo
     -1.4 (0.5) 12 mo
   beh=-2.1(0.2) 3 mo
     -2.5 (0.4) 6 mo
     -2.6 (0.5) 12 mo

*ANCOVA indicated no significant effect of group on BMI at 6 mo and 12 mo

 b) Systolic blood pressure (% change mean (SD)):
   min=-3.4(3.5) 3 mo
     -1.6(5.2) 6 mo
   ind=-3.2(3.5) 3 mo
     -7.5(4.8) 6 mo
     -6.8(5.8) 12 mo
   grp=-6.1(3.31) 3 mo
     -4.0(4.9) 6 mo
     -12.4(6.8) 12 mo
   beh=-9.0(2.4) 3 mo
     -11.2(3.2) 6 mo
     -16.9(3.8) 12 mo

 c) Diastolic blood pressure (% change mean (SD)):
   min=-4.9(1.4) 3 mo
     1.1(2.2) 6 mo
   ind=-4.1(1.8) 3 mo
     -4.2(1.8) 6 mo
     -5.3(3) 12 mo*
   grp=-5.5(1.9) 3 mo
     -3.3(2.4) 6 mo
     -5.0(4) 12 mo*
   beh=-9.1(1.8) 3 mo
     -11.6(1.9) 6 mo
     -7.9(2.6) 12 mo*

*ANCOVA indicated a significant effect of group on Diastolic blood pressure at 12 mo: p=.022

3) Events:
 a) Health care utilization:
   -Consulted Ophthalmologist (%)
   min=63 3 mo
     79 6 mo
   ind=67 3 mo
     85 6 mo
     97 12 mo
   grp=50 3 mo
     82 6 mo
     95 12 mo
   beh=57 3 mo
     78 6 mo
     89 12 mo

*Chi square indicated no significant effect of group at 6 mo and 12 mo

   -Consulted Podiatrist (%)
   min=12 3 mo
     27 6 mo
   ind=10 3 mo
     33 6 mo
     55 12 mo
   grp=21 3 mo
     53 6 mo
     73 12 mo
   beh=43 3 mo
     65 6 mo
     74 12 mo

*Chi square indicated a significant effect of group at 3 mo (p=.003) and 6 mo (p=.005)

 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

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: Different attrition rates across groups:
   min=0%
   ind=40% by mo
   grp=42% by 12 mo
   beh=9% by 12 mo;
   investigators note no control for provider