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Table 2 Primary intention-to-treat analyses of primary and secondary outcomes at 6 months for participants providing data

From: The community-based prevention of diabetes (ComPoD) study: a randomised, waiting list controlled trial of a voluntary sector-led diabetes prevention programme

 

Waiting list control group

Intervention group

Between group difference*

p-value

Baseline

n = 157

unless indicated

6-months

n = 144

unless indicated

Baseline

n = 157

unless indicated

6-months

n = 141

unless indicated

Mean (95% CI) or odds ratio (OR) (95% CI) where indicated

 

Primary outcome

 

 Weight loss (kg)

n/a

−0.10 (3.03)

n/a

−1.91 (4.49)

−1.72 (−2.59 to − 0.85)

<0.001

Secondary weight-related outcomes

 N (%) > 3% weight loss

n/a

23 (16)

n/a

46 (33)

OR = 2.53 (1.41 to 4.52)

0.002

 N (%) > 5% weight loss

n/a

12 (8)

n/a

29 (21)

OR = 2.83 (1.36 to 5.90)

0.006

 Mean (SD) BMI (kg/m2)

31.56 (4.39)

31.58 (4.60)

31.85 (4.66)

31.07 (4.53)

−0.64 (−0.95 to − 0.33)

<0.001

 Mean (SD) waist circumference (cm)

104.80 (11.28)

104.11 (11.48)

104.85 (12.62)

102.36 (12.50)

−1.36 (−2.36 to −0.36)

0.008

Other secondary objective outcomes

 Mean (SD) HbA1c (mmol/mol)

39.69 (2.73)

40.18a (3.22)

39.88 (3.06)

39.71 (5.70)

−0.76 (−1.73 to 0.21)

0.124

 Mean (SD) blood pressure systolic (mmHg)

137.58 (18.82)

138.44 (17.20)

136.22 (17.10)

136.91 (17.48)

−0.51 (−3.69 to 2.67)

0.752

 Mean (SD) blood pressure diastolic (mmHg)

79.83 (10.60)

79.85 (9.33)

78.97 (10.37)

78.21 (9.77)

−0.81 (−2.62 to 1.01)

0.383

 Mean (SD) total mins moderate-vigorous activity (MVPA) per week

318.67b (176.07)

312.95c (207.80)

337.34d (189.12)

332.05e (206.24)

−11.22 (−48.21 to 25.78)

0.551

 Mean (SD) total mins MVPA in 10+ min bouts per week

73.55b (96.67)

79.57c (127.99)

80.09d (116.85)

82.45e (130.36)

−8.23 (−30.92 to 14.46)

0.475

 N (%) meeting recommendation for 150 mins MVPA in 10+ min bouts per week

22b (16)

20c (19)

25d (17)

20e (18)

OR = 0.72 (0.31 to 1.68)

0.448

Secondary self-reported outcomes

 Dietary behaviour fat subscale scores (0 to 3, lower better)

1.95f (0.39)

1.92g (0.33)

1.94 (0.30)

1.81h (0.33)

−0.11 (−0.18 to −0.05)

0.001

 Dietary behaviour fibre subscale score (0 to 3, higher better)

2.17f (0.40)

2.19g (0.42)

2.17 (0.38)

2.30h (0.38)

0.12 (0.05 to 0.20)

0.001

 Mean (SD) health rating (0–100, higher better)

75.09i (17.37)

73.65j (18.49)

72.78k (19.95)

77.24h (16.66)

4.48 (0.85 to 8.11)

0.016

 Mean (SD) life satisfaction rating (0–10, higher better)

7.43i (1.90)

7.48j (1.96)

7.65 (2.03)

7.73h (1.74)

0.14 (−0.18 to 0.46)

0.385

 Mean (SD) mental well-being scores (0–35, higher better)

24.88f (5.09)

24.07h (5.02)

24.82 (4.69)

24.99h (3.89)

0.04 (−0.21 to 0.28)

0.761

  1. *Mean differences, ORs and CIs adjusted for baseline outcome value, site, gender, age and baseline BMI category
  2. an = 142, 2 participants missing HbA1c due to machine malfunction;
  3. bn = 135, cn = 104, dn = 143, en = 112, with 4+ valid days, including a weekend day, of accelerometry data
  4. fn = 154; gn = 141; hn = 140; in = 152; jn = 139; kn = 156