Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- 1f. Primary Outcome: Dietary Intake ASA24 (Sodium)
研究概览
简要总结
Dietary intake is a powerful, modifiable factor that influences cancer risk. Unfortunately, most adults in the U.S. find it difficult to adhere to dietary guidelines for cancer prevention. One promising pathway for improving dietary adherence is to target grocery shopping habits, i.e., foods purchased for consumption at home. Two-thirds of daily food intake is sourced from or eaten in the home, so improving the quality of the home food environment should improve overall diet quality. When healthy foods are purchased and unhealthy foods are not, minimal self-control is needed to make healthy eating choices in the home. At the point of purchase, it is difficult to resist the temptation of palatable foods, but interventions might facilitate healthy choices by promoting dietary goal salience in real-time while grocery shopping, enhancing motivation to make and sustain changes to the diet, and increasing household support and accountability for healthy food purchasing. The proposed study will enroll adults who have low adherence to cancer prevention dietary recommendations. All participants will attend a nutrition education workshop conducted via Zoom. For 20 weeks, all participants also will receive once weekly reminders and recommendations for food purchasing via an app. The study will experimentally test four additional intervention components: location-triggered messages, coaching monitoring of food purchases, benefit of change content, and household member involvement. The preliminary aim of the study is to assess feasibility and acceptability of the intervention components. The primary aim of the study is to quantify the effect of each intervention component, individually and in combination, on dietary intake (assessed with 24-hour food recalls). The overarching goal of this project is to optimize this mHealth intervention, which can be tested in the future in a fully powered clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will be blind to condition.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
1f. Primary Outcome: Dietary Intake ASA24 (Sodium)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in mg of sodium consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1b. Primary Outcome: Dietary Intake ASA24 (Fruit/Veg)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in number of cups of fruits and vegetables per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1c. Primary Outcome: Dietary Intake ASA24 (Red Meat)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in ounces of red meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1d. Primary Outcome: Dietary Intake ASA24 (Processed Meat)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in ounces of processed meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1e. Primary Outcome: Dietary Intake ASA24 (Added Sugars)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of added sugars consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1h. Primary Outcome: Dietary Intake ASA24 (Sugar-Sweetened Beverages)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in oz of sugar sweetened beverages consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2b. Dietary Intake: DHQ-III (Fruits/Veg)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in cups of fruits and vegetables per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1g. Primary Outcome: Dietary Intake ASA24 (Fat)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of saturated fat consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2c. Dietary Intake: DHQ-III (Red Meat)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in oz of red meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2e. Dietary Intake: DHQ-III (Added Sugars)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of added sugars consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2f. Dietary Intake: DHQ-III (Sodium)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in mg of sodium consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2a: Dietary Intake: DHQ-III (Fiber)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of fiber per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2d. Dietary Intake: DHQ-III (Processed Meat)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in oz of processed meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2g. Dietary Intake: DHQ-III (Fat)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of saturated fat per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2h. Dietary Intake: DHQ-III (Sugar-Sweetened Beverages)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in ounces of sugar-sweetened beverages per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1a. Dietary Intake: ASA24 (Fiber)
时间窗: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of fiber per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
次要结局
- Dietary Intake - FFQ (Guideline 1)(0, 10, 20 weeks)
- Treatment Acceptability: 20 Weeks(20 weeks (post-treatment))
- Dietary Intake-household Member(0, 20 weeks)
- Treatment Acceptability - Household(20 weeks)
- Social Support (Discouragement)(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Autonomous Motivation(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Social Support (Encouragement)(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Weight History(0 weeks (Baseline))
- Goal Salience(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Supportive Accountability(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Uncontrolled Eating(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Goals and Stages of Change- Household Member(0 weeks)
- Dietary Intake- Household Member - FFQ (Guideline 1)(0, 20 weeks)
- Dietary Intake-household Member - FFQ - Guideline 4(0, 20 weeks)
- External Motivation(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Quality of Household Relationship(Baseline)
- Emotional Eating(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Dietary Intake - Household Member - FFQ (Guideline 2)(0, 20 weeks)
- Dietary Intake-household Member - FFQ (Guideline 3)(0, 20 weeks)
- Dietary Restraint(0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment))
- Dietary Intake - FFQ (Guideline 2)(0, 10, 20 weeks)
- Dietary Intake - FFQ (Guideline 3)(0, 10, 20 weeks)
- Dietary Intake - FFQ (Guideline 4)(0, 10, 20 weeks)
- Treatment Acceptability: 10 Weeks(10 weeks (mid-treatment))
研究者
Meghan Butryn
Associate Professor of Psychology
Drexel University