Talking Health, A pragmatic randomized-controlled health literacy trial targeting sugar-sweetened beverage consumption among adults: Rationale, design & methods

Abstract

High consumption of sugar-sweetened beverages (SSB) contributes to a wide range of poor health outcomes. Further, few US adults drink less than the recommended ≤8 ounces per day; and individuals with low socioeconomic, low health literacy status, and in rural areas are even less likely to meet recommendations. Unfortunately, few SSB behavioral interventions exist targeting adults, and none focus on low health literacy in rural areas. Talking Health, a type 1 effectiveness-implementation hybrid trial targeting adults in rural southwest Virginia, was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore). SIPsmartER was developed based upon the Theory of Planned Behavior and uses health literacy strategies to improve comprehension of the intervention content among participants. MoveMore is based on a research-tested intervention that was adapted to address all theory of planned behavior constructs and health literacy principles. Secondary aims include additional health outcomes (e.g., physical activity, weight) and reach, adoption, implementation, and maintenance indicators. This paper highlights the opportunities and considerations for developing health behavior trials that aim to determine intervention effectiveness, provide all study participants an opportunity to benefit from research participation, and collect key information on reach and the potential for organizational adoption, implementation, and maintenance with the longer-term goal of speeding translation into practice settings.

Dietary quality changes in response to a sugar-sweetened beverage–reduction intervention: results from the Talking Health randomized controlled clinical trial

“…Detailed trial information has been presented elsewhere (7,30). The SIPsmartER group's primary intervention goal was to reach the recommendation of ,240 mL SSBs/d (,8 fl oz SSBs/d) (18,32), and the MoveMore group's primary intervention goal was to reach 150 min of moderate-intensity aerobic activity and musclestrengthening activities on $2 d/wk (30).…”

“…Participants were recruited from medically-underserved rural regions (Medical Underservice Index score #62) (33) in Southwest Virginia for the Talking Health trial (7). Recruitment details have been published elsewhere (7); briefly, participants were recruited from April 2012 to June 2014 through various active recruitment methods (daycare centers, festivals, health and free clinics, health departments, and local extension agents) and passive recruitment methods (targeted mailings, flyers, radio announcements, and newspaper advertisement).…”

“…Recruitment details have been published elsewhere (7); briefly, participants were recruited from April 2012 to June 2014 through various active recruitment methods (daycare centers, festivals, health and free clinics, health departments, and local extension agents) and passive recruitment methods (targeted mailings, flyers, radio announcements, and newspaper advertisement). Information regarding eligibility and enrollment has been presented elsewhere (7). Briefly, 1056 individuals were screened, 620 of whom were eligible, and 301 subjects were enrolled.…”

“…Because w50% of AS consumption is from sugar-sweetened beverages (SSBs) (5), reducing SSB intake is a common objective of AS-reduction interventions (6,7) and public health policies (8)(9)(10). Recently, the US Dietary Guidelines recommended that #10% of energy should come from AS and that SSBs should be replaced with water (11).…”

“…These secondary data were from the Talking Health study, which was a randomized controlled trial that targeted adults with low socioeconomic status (7). Participants were randomly assigned to the SIPsmartER intervention (SSB reduction) or to the MoveMore comparison group (physical activity).…”