Table 2.
Fit Forward trial measures and schedule
Measure | Construct | Description | Timeline |
---|---|---|---|
Anthropometric | Weight (primary outcome), Waist circumference, Height, Body mass index | Measured in lbs. in light indoor clothing without shoes using a calibrated digital scale. Waist circumference measured to the nearest 0.1 cm with an anthropometric tape on a horizontal plane at the iliac crest landmarks. Height measured without shoes with a medical grade stadiometer to the nearest 0.1 cm at entry into the study. Body mass index: will be calculated from measured height and weight (kg)/height(m)2. | B, 6, 12 |
Physical Health | Lipid profile | Assessed with the CLIA-waived CardioChek Plus analyzer. Non-fasting values include total cholesterol, HDL, LDL, triglycerides, and total cholesterol/HDL ratio. | B, 6, 12 |
HgA1c | Assessed with the CLIA-waived A1cNow+ device for an immediate HgA1c percent. | B, 6, 12 | |
Blood pressure | Blood pressure assessed on the right arm of participants after they rest quietly in a seated position for at least 5 minutes, using a validated automated medical grade sphygmomanometer. | B, 6, 12 | |
Medication use | Self-reported list of prescribed medications taken at the time of the study. | B, 6, 12 | |
Cardiorespiratory fitness (primary outcome) | Cardiorespiratory fitness will be assessed using the 6-Minute Walk Test (6-MWT) [26]. The 6-MWT assesses cardiovascular endurance by instructing the individual to complete as many laps as possible in 6 minutes on a flat, hard surface. An increase in distance of more than 50 m on the 6-MWT has been associated with clinically significant reductions in risks for cardiovascular disease [27]. This measure has been used to detect clinically significant changes in fitness in prior health promotion trials with people with SMI [6, 7]. | B, 6, 12 | |
Mental Health | Psychiatric Diagnosis | Primary medical record diagnosis, verified from a participant’s chart. | B |
Depressive Symptoms | The Center for Epidemiologic Studies Depression (CES-D) Scale will be used to assess depressive symptoms [28]. The CES-D is a 20-item self-report measure that asks participants to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. | B, 6, 12 | |
Physical Activity | Physical activity | We will use the 9-item International Physical Activity Questionnaire (IPAQ) short form self-report measure to assess the number of days per week and the amount of time per day participants’ spent in physical activity during the 7 days prior to the interview [29]. Summary scores will be calculated for vigorous activities obtaining an estimate of weekly metabolic equivalent expenditure (MET) minutes of vigorous physical activity. The reliability and validity of the IPAQ for use among persons with serious mental illness is comparable to that in the general population [30]. | B, 6, 12 |
Sedentary activity | The Sedentary Behavior Questionnaire (SBQ) assesses the number of hours participants spend engaging in nine sedentary behaviors. Response options range from “15 minutes or less” to “6 hours or more.” Higher scores on the SBQ indicate more time performing sedentary behaviors. The SBQ has acceptable measurement properties for use among overweight adults [31]. | B, 6, 12 | |
Dietary Behaviors | Daily meal patterns | This measure identifies an individual's typical meal pattern and was adapted from the NIH Early Adult Reduction of weight through LifestYle intervention (EARLY) Trials [32]. It determines the number of times a respondent (a) eats breakfast; (b) eats a mid-morning snack; (c) eats lunch; (d) eats a midafternoon snack; (e) eats dinner; (f) eats an evening snack; and (g) eats within an hour of bedtime in a typical week. | B, 6, 12 |
Eating away from home | The Eating Away from Home Questionnaire assesses the frequency with which an individual consumed food outside the home (e.g., fast food, restaurant buffets) in the past 30 days [32]. Respondents also report the number of days over the past week that they prepared breakfast, lunch, or dinner at home. | B, 6, 12 | |
Sugar sweetened beverage consumption | The Sugar Sweetened Beverages Survey is a self-report measure adapted from the NCI Diet History Questionnaire [33] that assesses the amount of sugar-sweetened beverages, including soda and sports drinks, consumed in a typical week. | B, 6, 12 | |
Self-Weighing Behaviors | Weight self-monitoring | Four items from the Weight History Questionnaire developed for the National Health and Nutrition Examination Survey (NHANES) will be used to assess participants’ perception of their weight (e.g., overweight), what they are trying to do about it (e.g., lose weight), their highest weight, and frequency of self-weighing [34]. | B, 6, 12 |
Weight control strategies | The Weight Control Strategies Scale (WCSS) is a self-report measure used to assess use of specific strategies for losing weight or maintaining weight loss in the past month. The 30-item WCSS contains 4 subscales: Dietary Choices, Self-monitoring Strategies, Physical Activity, and Psychological Coping. The WCSS subscales and total score have good internal consistency reliability in a weight loss treatment seeking sample of overweight and obese individuals [35]. | B, 6, 12 | |
Mediators | Exercise self-efficacy | The Exercise Self-efficacy measure assesses participants’ confidence in their ability to persist in exercising in various situations [36]. Five items represent the following areas: negative affect, resisting relapse, and making time for exercise. Respondents rate their confidence on a five-point Likert scale. Higher overall scores indicate higher exercise self-efficacy. | B, 6, 12 |
Perceived social support | Perceived social support is assessed with the brief, multidimensional 19-item Social Support Survey that assesses four domains of social support: (1) emotional support/informational support, (2) tangible support, (3) positive social interactions, and (4) affectionate support. Higher subscale and total scores indicate higher levels of perceived social support from friends and family members [37]. | B, 6, 12 | |
Peer Group Support (PeerFIT only) | The Group Climate Questionnaire-Short Form (GCQ) is a self-report measure of the group member’s perception of the group atmosphere [38]. Participants rate items on a 7-point Likert scale “not at all” to “extremely.” The GCQ has three subscales: Engagement, which is composed of items pertaining to self-disclosure, cognitive understanding, and confrontation; Avoidance, with items measuring the extent that group members avoid responsibility for their change processes; and Conflict, which measures interpersonal conflict and distrust. The Social Provisions Scale consists of 10-items across five subscales that measure the participant’s perception of social support availability in the PeerFIT group: emotional support or attachment, social integration, reassurance of worth, tangible help, and orientation [39]. The items are rated on 4-point Likert scales from “strongly disagree” to “strongly agree,” and higher scores indicate greater perceived support from group relationships. We will measure group cohesion in the PeerFIT intervention with the 25-item Group Cohesion Scale-Revised [40], which assesses participants’ perception of group cohesion across domains including interaction and communication, member retention, decision making, vulnerability among group members, and consistency between group and individual goals. Participants rate the extent to which they experience group cohesion on each of the domains from 1= strongly disagree to 4 = strongly agree across, and items are summed with higher subscale scores and total scores indicating more cohesion. | 6, 12 | |
Other*** Questionnaires | Demographic data | Client demographics instrument developed by our research group, includes items such as age, race, ethnicity, marital status, education, employment, living situation, and number of times hospitalized for psychiatric conditions. | B |
Tobacco and alcohol use | A series of questions adapted from the Behavioral Risk Factor Surveillance System (BRFSS) will be used to asses tobacco and alcohol use, including frequency and amount of use [41]. | B, 6, 12 | |
Sleep habits | The Pittsburg Sleep Quality Index is a 19-item measure that assesses an individual’s quality of sleep over the past month, including sleep latency, duration of sleep, sleep efficiency, frequency of sleep-related problems, use of pharmacological sleep aids, and impaired daytime functioning [42]. Higher scores indicate poorer sleep quality. | B | |
Parental contact | Frequency of contact with parents will be assessed by asking participants to report the type of contact (in person, telephone phone, and/or text message) and amount of contact in the past year with the parent with whom they have had the most contact. | B | |
Built Environment | The 17-item Physical Activity Neighborhood Environment Survey (PANES) will be used to asses environmental factors that influence walking and bicycling in participants’ neighborhoods [43]. Respondents rate their level of agreement with statements regarding different aspects of the built environment in which they live on a four-point Likert scale (1=Strongly disagree to 4=Strongly agree). Higher scores on the PANES indicate greater environmental support for physical activity. | B | |
Technology use | Developed and piloted tested by our research team [44], the Consumer Technology Use Survey includes 39 items that assess the use of mobile phones, smartphones, personal computers, the Internet, and popular social media among persons with serious mental illness. | B | |
Adherence | Attendance at lifestyle sessions | The PeerFIT and BEAT lifestyle coaches record attendance electronically at each session. | 0-6 mo |
Attendance at exercise sessions | The PeerFIT lifestyle coach records attendance electronically at each exercise session. | 0-6 mo | |
Wearable activity tracker adherence | Measured as the proportion of days the participant wore the Fitbit device during the 12 months of study participation. | 0-12 mo | |
Facebook group adherence | Number of participants who used the Facebook group and number of interactions (including posts, comments, or “likes”) in the Facebook group. | 0-12 mo |