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Table 2 Acceptability and study rigor and conduct data, with thresholds for assessing feasibility of future definitive randomized controlled trial

From: A multi-center, randomized, 12-month, parallel-group, feasibility study to assess the acceptability and preliminary impact of family navigation plus usual care versus usual care on attrition in managing pediatric obesity: a study protocol

Methodological issues

Commentsa

Feasibility dataa

Criteriab

Feasible? (Y/N)

Need to modify pre-RCT? (Y/N)

1.Was the Family Navigation intervention acceptable to children and caregivers based on the 7 domains from the Theoretical Framework of Acceptability (TFA), including:

a. Affective attitude

b. Burden

c. Perceived effectiveness

d. Ethicality

e. Intervention coherence

f. Opportunity costs

g. Self-efficacy

(e.g., data from 1-on-1 interviews)

(e.g., data will be analyzed using thematic analysis, which precludes quantification; 7 themes, plus additional sub-themes)

For each of the 7 domains, findings will be reviewed, discussed, and interpreted with our Stakeholder Committee and research team to determine whether parts of the Family Navigation intervention should remain unchanged or if changes are needed before implementing in our definitive RCT

(e.g., “yes” for all 7 domains)

(e.g., “yes” for 1 domain; “no” for 6 domains)

2.What proportion of participants approached were eligible?

  

 ≥ 90% approached were eligible

  

3.Did recruited participants complete consent/assent procedures?

  

 ≥ 95% recruited participants completed consent/assent procedures

  

4.Did recruitment lead to successful enrollment?

  

100% sample size goal achieved

  

5.Did participants agree to randomization?

  

 ≥ 95% participants agreed to be randomized

  

6.Did randomization yield equality across groups?

  

Equal numbers of participants randomized to experimental and control groups

  

7.Were blinding procedures effective?

  

100% analysts remained blinded to group assignment

  

8.Were outcome assessments completed?

  

 ≥ 95% participants retained in the study completed outcome assessments

  

9.How complete were outcome assessments at all study measurement intervals?

  

 ≥ 95% outcome assessments were complete

  

10. Were outcome assessments burdensome for families?

  

 ≥ 90% children and caregivers disagreed that outcome assessments were burdensome

  

11. Was study protocol acceptable to children and caregivers?

  

 ≥ 90% children and caregivers agreed study protocol was acceptable

  

12. Was the level of attrition adequate within experimental (Family Navigation + Usual Care) and control (Usual Care only) groups at 12 months?

  

Experimental (FN + UC): 15–25% attrition

Control (UC): 30–40% attrition

  

13. Was collection of attrition data adequate to calculate sample size for definitive RCT?

  

 ≥ 95% participants had attrition data collected by 12 months post-baseline

  

14. Were logistics of running a multi-center trial assessed?

  

Review procedures (ongoing and end-of-grant) with investigators, research staff, navigators

  

15. Did all components of the protocol work together adequately?

  

Review procedures (ongoing and end-of-grant) with investigators, research staff, navigators

  
  1. aComments and Feasibility Data columns will be populated with study data collected during our study; example provided for context
  2. bCriteria column thresholds based on objective criteria (when possible) and experience gained through study implementation as well as data analysis and interpretation with Stakeholder Committee and research team