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. 2014 Sep 4;2014(9):CD006424. doi: 10.1002/14651858.CD006424.pub3

Agurs‐Collins 1997.

Methods Parallel randomised controlled clinical trial (RCT)
Randomisation ratio: 1:1
Superiority design
Participants Inclusion criteria:
  • Obese individuals of African American origin

  • Age equal to or > 55 years; diagnosis of type 2 DM

  • Equal to or > 120% weight standards

  • HbA1c > 8%; ambulant

  • No medical contraindications for exercise


Exclusion criteria: not explicitly stated (but see inclusion criteria)
Diagnostic criteria: by medical history
Interventions Number of study centres: not stated
Treatment before study: not stated if previous HE
Intervention: weekly nutrition sessions (60 minutes) with exercise training (30 minutes) for 3 months; following 3 months on biweekly problem‐solving (90 minutes) sessions. Also 1 individual counselling session
Control: 1 class on glycaemic control at 3 weeks from start; 2 letters with written information on nutrition. Participants were given the results of blood tests
Provider: dietician and exercise physiotherapist with experience in working with African Americans
Outcomes Outcomes reported in abstract of publication:
Primary outcomes(s):
HbA1c (hypothesis testing)
Secondary outcome(s):
  • Weight

  • BMI

  • Waist/hip ratio

  • Systolic and diastolic blood pressures

  • Lipid profile

  • Physical activity

  • Nutrition knowledge

  • Dietary components

Study details Run‐in period: not stated
Study terminated before regular end: yes—stopped before target of 40 per treatment arm because of time and funding constraints
Publication details Language of publication: English
Funding: dissertation research grant, partially funded by the National Institute of Aging and the National Institutes of Health
Publication status: peer review journal
Stated aim of study Quote from publication: "The objective was to evaluate a weight loss and exercise programme designed to improve diabetes management in older African Americans"
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from publication: "Randomization was supervised by the study statistician..."
 Comment: split into groups depending on medication or dietary therapy, and then "assigned randomly with 1:1 ratio within medication strata"
Allocation concealment (selection bias) Unclear risk Comment: no mention
Blinding of participants and personnel (performance bias) 
 Objective outcomes High risk Quote from publication: "One of the authors, a registered dietician experienced in working with older African‐Americans delivered the intervention program..."
 Comment: participants and staff not blinded because of the nature of the study
Blinding of participants and personnel (performance bias) 
 Subjective outcomes High risk Comment: not blinded
Blinding of outcome assessment (detection bias) 
 Lab tests: Lipids, HBA1C Unclear risk Comment: no mention of whether laboratory staff/outcome assessors for BP were blinded
Blinding of outcome assessment (detection bias) 
 Subjective outcomes High risk Comment: participants completing questionnaires unlikely to have been blinded
Incomplete outcome data (attrition bias) 
 Objective outcomes Unclear risk Comment: unequal loss to follow‐up, no mention of ITT analysis
Incomplete outcome data (attrition bias) 
 Subjective outcomes Unclear risk Comment: as above
Selective reporting (reporting bias) Unclear risk Comment: protocol not available
Other bias Unclear risk Comment: none