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Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention
NA trial testing Core Behavioral Weight Loss Intervention in Obesity in 32 participants. Completed in 14 April 2024.
| Lead sponsor | Stanford University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 5 December 2023 |
| Primary completion | 9 April 2024 |
| Estimated completion | 14 April 2024 |
| Sites | 1 location across United States |
Stanford University
18 and older, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
average percentage of days in the 10-week intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 89 | 69 – 99 |
average percentage of days in the 10-week intervention of self-monitoring steps (assessed objectively via Fitbit activity tracker); a benchmark of self-monitoring 75% of days would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| Step Goal: Easier | 100 | 90 – 100 |
| Step Goal: Harder | 100 | 98 – 100 |
average percentage of days in the 10-week intervention of self-monitoring dietary intake (assessed via Fitbit mobile app); a benchmark of self-monitoring 75% of days would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| Calorie Goal: Easier | 54 | 20 – 93 |
| Calorie Goal: Harder | 79 | 41 – 92 |
1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 29 |
the proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| Calorie Goal: Easier | 14 | |
| Calorie Goal: Harder | 16 | |
| Step Goal: Easier | 15 | |
| Step Goal: Harder | 15 | |
| Eating Window Goal: Easier | 15 | |
| Eating Window Goal: Harder | 15 | |
| Red Zone Food Goal: Easier | 15 | |
| Red Zone Food Goal: Harder | 15 |
the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 30 |
average percentage of days in the 10-week intervention of meeting the daily calorie goal (assessed via Fitbit mobile app); a benchmark of 75% of days would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| Calorie Goal: Easier | 43 | 14 – 59 |
| Calorie Goal: Harder | 29 | 13 – 41 |
average percentage of days in the 10-week intervention of meeting the daily step goal (assessed via Fitbit activity tracker); a benchmark of 75% of days would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| Step Goal: Easier | 34 | 24 – 45 |
| Step Goal: Harder | 32 | 16 – 60 |
average percentage of days in the 10-week intervention of meeting the daily eating window goal (assessed via survey); a benchmark of 75% of days would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| Eating Window Goal: Easier | 67 | 43 – 93 |
| Eating Window Goal: Harder | 81 | 68 – 93 |
average percentage of days (out of days instructed to track Red Zone Foods) in the 10-week intervention of meeting the daily Red Zone Food goal (assessed via survey); a benchmark of 75% of weeks would indicate feasibility
| Group | Value | 95% CI |
|---|---|---|
| Red Zone Food Goal: Easier | 46 | 8 – 96 |
| Red Zone Food Goal: Harder | 54 | 35 – 94 |
percentage change in weight from baseline to 10 weeks (end of intervention); assessed objectively via smart scale
| Group | Value | 95% CI |
|---|---|---|
| Calorie Goal: Easier | -2.72 | ± 3.63 |
| Calorie Goal: Harder | -4.86 | ± 3.30 |
| Step Goal: Easier | -3.45 | ± 3.81 |
| Step Goal: Harder | -4.13 | ± 3.42 |
| Eating Window Goal: Easier | -4.19 | ± 2.79 |
| Eating Window Goal: Harder | -3.39 | ± 4.28 |
| Red Zone Food Goal: Easier | -3.98 | ± 2.94 |
| Red Zone Food Goal: Harder | -3.60 | ± 4.21 |
The goal of this pilot trial is to learn about the optimal intensity level of goals in a digital weight loss intervention among adults with overweight or obesity. The main questions of the study are to assess the feasibility and acceptability of different goal intensities across four domains (calorie goal, step goal, eating window goal, red zone food goal). The investigators will recruit 32 total participants to the trial. Recruitment will occur through remote channels. Interested individuals will be directed to an online screening questionnaire; those who are eligible will then be invited to attend an initial remote session with study personnel to ensure interest and eligibility in the study. The weight loss intervention will last 10 weeks, and all participants will receive a "core" treatment consisting of self-monitoring weight, food intake, and steps (all via digital tools provided by the study team), along with behavioral lessons, action plans, and tailored feedback. Depending on which group participants are assigned to in the study, individuals will receive either a more or less challenging goal across the four domains. All study tasks will occur remotely, thus, participants will never come in-person for any tasks. Assessment of body weight and other measures will occur at the beginning of the trial ("baseline"), and at 4 weeks and 10 weeks. The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify which of the goal intensity levels result in meaningful engagement and weight loss. The current study is the first step towards answering this question; it is designed as a pilot factorial trial, which focuses on feasibility and acceptability. In total, there will be 16 treatment conditions.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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