Tate 2012.

Methods	Design: RCT Timing: Prospective Allocation to group: Quote: "Eligible participants were randomly assigned as cohorts after baseline measures by using a computer‐generated random‐numbers method by the project coordinator with allocation concealed from the participants and investigators until randomization was revealed to the study participants at the initial group session" Number of clusters or sites: N/A Number of individuals: 318 Length of intervention: 6 months
Participants	General description of participants: Overweight or obese adults consuming at least 280 kcal/d of caloric beverages, living in the Raleigh‐Durham area in North Carolina, USA Age: Adults (aged 18 ‐ 65 years) Inclusion criteria: Quote: "18‐65 years of age; body mass index (BMI) between 25.0‐49.9 kg/m2; subject consumes at least 280 calories per day from caloric beverages" Exclusion criteria: Quote: "[R]eport losing >5% of current body weight in the previous 6 months; report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.); report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months; report taking medication that could affect metabolism or change body weight (e.g., synthroid); report hospitalization for psychiatric problems during the prior year; report major psychiatric diagnoses and organic brain syndromes; report heart problems, chest pain, cancer within the last 5 years; being treated by a therapist for psychological issues or problems with psychotropic medications; report behaviors that indicate probable alcohol dependence as assessed by the Rapid Alcohol Problems Screen (RAPS4‐QF); unwilling to change intake of beverages during the study period; plan to move from the area during the study period, and/or unable to attend monthly group meetings; report not having adequate transportation to the study center that would allow transport of study supplies back to the subject's home; report not being able to attend group meetings on Monday or Tuesday evenings" Recruitment: Quote: "We recruited, enrolled, and followed participants between May 2008 and January 2010 at UNC–Chapel Hill, North Carolina" (no further information provided) Weight status at baseline: Overweight or obese (a BMI between 25 and 50 was an inclusion criterion; mean baseline BMI was 37 in the CG and 38 in both IGs) SSB consumption at baseline: Intake of at least 280 kcal/d of caloric beverages was an inclusion criterion; SSB consumption at baseline is not reported, only energy intake from beverages in general, which was 320 kcal/day in the control group, 390 kcal/day in the diet beverage group, and 327 kcal/day in the water group Equity considerations: Participants lived in the Raleigh‐Durham area in North Carolina, USA. A variety of ethnic groups (approximately 55% were black, 40% were white, and 5% other), educational groups (approximately 7% high school or less, 40% some college, and 53% college graduate or beyond) and both sexes (85% female and 15% males) were represented
Interventions	Intervention: Provision of water and diet beverages to participants at monthly group meetings, for transportation to their homes (Quote: “Both of the intervention groups received noncaloric beverages [water or noncaloric sweetened ('diet') beverages] (…). On the basis of previous research, four 355–500‐mL (12–16 oz) single‐serving beverages per person per day were provided to ensure availability, with 2 additional servings per day to account for family members’ occasional consumption, although this was discouraged. Participants in the Water group could choose any combination of bottled still and nonsweetened sparkling water. Similarly, participants in the DB group were provided any combination of noncaloric sweetened beverages of their choice, including carbonated, noncarbonated, noncaffeinated, and caffeinated beverages. Both the Water and DB groups were given beverages at their monthly treatment group meeting“) Behavioural co‐intervention: Dietary counselling focused on beverages (Quote: "Both of the intervention groups received (…) monthly group behavioral counseling to promote adherence to beverage substitution. The recommendations for each of these groups were identical except for the substituted beverage. Participants were encouraged to replace ≥2 servings (≥200 kcal) per day of caloric beverages with either water or DBs [diet beverages]") Control: General weight‐loss counselling (Quote: "The AC group was designed to equate treatment contact time and attention, monthly weigh‐ins, and weekly monitoring to facilitate study of the additional benefit of beverage change. This group, called 'Healthy Choices', attended monthly group sessions of identical length to the beverage groups. They were weighed and given general weight‐loss information (eg, instructed to read product labels, increase vegetable consumption, control portions, and increase physical activity); they were not given weight‐loss calorie‐reduction or physical activity goals. They were not encouraged to change beverage intake (beverages were not mentioned during the lessons or group sessions) and were not provided with beverages")
Outcomes	Measures of SSB intake: Total energy intake from beverages (kcal/d), assessed through 24‐hour dietary recall at baseline, 3 and 6 months Measures of intake of alternatives to SSB: Water and diet beverage intake (g/d), assessed through 24‐hour dietary recall at baseline, 3 and 6 months (reported in the 2‐arm comparison presented in Piernas 2013 only) Anthropometric measures: Weight (kg) and waist circumference (cm), assessed with a standardised clinical protocol at baseline, 3 and 6 months Adverse outcomes: The study does not report how data on adverse outcomes were collected, and if adverse outcomes were observed or not Other outcomes: Total energy intake from solid foods (kcal/d), assessed through 24‐hour dietary recall at baseline, 3 and 6 months; blood glucose (mg/dl), systolic and diastolic blood pressure, and urine osmolality, assessed at baseline, 3 and 6 months
Context and implementation	Setting: Participants' homes Sector: Health care Country: USA Year(s) when implemented: 2008 ‐ 2010 Mode of implementation: Pilot trial by researchers Level of implementation: Setting‐based intervention
Declarations	COI: "None of the authors has or had any conflicts of interest. Nestle´ Waters USA had no involvement in the study design, conduct, or preparation and review of this manuscript" Funding: "Supported by an investigator‐initiated research grant to University of North Carolina from Nestle´ Waters USA. Water was provided by Nestlé Waters USA" Trial registration: ClinicalTrials.gov number NCT01017783 Protocol availability: Protocol mentioned in the report but not publicly available
Notes	We combined the 2 outcome categories 'water' and 'beverages with low calorie sweeteners' and report these outcomes both separately and as combined outcome. For the data reported in the 3‐arm comparison we combined the 2 intervention arms to create a 2‐arm comparison
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Eligible participants were randomly assigned as cohorts after baseline measures by using a computer‐generated random‐numbers method by the project coordinator"
Allocation concealment (selection bias)	Low risk	Quote: "[A]llocation [was] concealed from the participants and investigators until randomization was revealed to the study participants at the initial group session"
Similarity of baseline outcome measurements (selection bias)	Low risk	For weight, waist circumference and blood pressure, baseline outcome measurements were similar. Energy intake from beverages differed between groups, but confidence intervals overlap
Similarity of other baseline characteristics (selection and performance bias)	Low risk	No significant differences in baseline characteristics between the 3 groups were observed (see table 1 of the study's primary report)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition was low (approx. 15%) and similar across groups. Results are based on an intention‐to‐treat analysis with imputed data, and we conducted a sensitivity analysis for imputation. Quote: "For continuous variables, the Markov Monte Carlo method was used to impute missing data by generating a total of 10 imputations. Results from the imputations were combined by using PROC MIANALYZE in SAS. In a secondary analysis of study completers, results were consistent with the findings of the multiple imputation analysis except with respect to BP [blood pressure]"
Blinding (performance and detection bias) Subjective outcomes	High risk	Dietary intake was self‐reported, and blinding of participants was not possible
Blinding (performance and detection bias) Objective outcomes	Low risk	Participants were not blinded, but the outcomes (body weight and waist circumference) were objective and assessed based on a standardised clinical protocol
Contamination (performance bias)	Low risk	Contamination seems unlikely. Quote: "After the participants’ specific substitution group was revealed, the substitution for the other study group was not revealed, and the controls were not informed of either substitution until all cohorts were completed"
Selective reporting (reporting bias)	Unclear risk	The trial was registered towards the end of the study, and no published protocol is available. SSB consumption and BMI were inclusion criteria and assessed, but are not reported in the main 3‐arm comparison (the study does, however, report energy intake in kcal/day, waist circumference and body weight in kg as outcomes). The study does not report if outcomes were prespecified or not, and there are some differences between the outcomes listed as primary and secondary outcomes in the trial registry and those reported in the study reports
Other bias	Low risk	No other concerns