Optimization of Dietary Adherence in a Mobile Weight Loss Intervention
2026年5月13日 更新者：UNC Lineberger Comprehensive Cancer Center
Optimizing Dietary Adherence in a Mobile Behavioral Weight Loss Intervention for Adults
The goal of this study is to test multiple individual treatment components added to a 6-month standard mobile behavioral weight loss program that are intended to help participants follow dietary recommendations and meet their dietary goals more often.
The four components to be studied include switching dietary tracking methods, receiving access to a goal planning tool, receiving additional personalized text messages, and receiving three sessions with a health coach.
The study will identify the best combination of these additional treatments for improving total number of weeks in the program that participants meet their dietary goals.
調査の概要
状態
まだ募集していません
条件
詳細な説明
SHIFT uses a highly efficient experimental design as part of the Multiphase Optimization Strategy (MOST) to optimize a 6-month behavioral weight loss intervention for improved dietary adherence among adults with overweight and obesity with initial nonresponse to the intervention. Investigators will test four unique treatment components added to a core mobile behavioral weight loss program.
All participants will receive the Core 6-month behavioral weight loss program, which is a comprehensive intervention that includes evidence-based behavior change strategies to promote self-monitoring and adherence to personalized dietary and activity goals. The program includes an individual kick-off session, native smartphone application, text messages, daily goals, self-monitoring of diet, weight, and physical activity, weekly lessons, tailored weekly feedback, and will start with 5-6 text messages per week. The intervention targets both dietary and physical activity changes, with a greater emphasis placed on improved dietary behaviors as the primary strategy for weight loss. Participants with lower than expected adherence to their dietary goals early in the program (weeks 3-8; "nonresponders") will be randomly assigned in a 2x2x2x2 factorial trial to the On or Off level of each of these 4 additional treatments added onto the core program: 1) switching dietary self-monitoring approach (Simplified Diet), 2) adding an autonomous goals and planning tool (Goal Autonomy + Planning), 3) adding just-in-time text messaging (JIT Messaging) 4) receiving 3 telehealth sessions with a health coach (Coach). Thus, each of these participants will receive 0-4 additional treatment components for the remainder of the 6-month program. Participants with recommended levels of dietary adherence in the first 8 weeks ("responders") remain in the Core program and are not randomized in the factorial trial.
All participants (those in the factorial trial and the responders who remain in the Core only) will complete assessments at baseline, 4 weeks (brief/online only), 8 weeks (brief/online only), 3 months, and 6 months. Primary and secondary research aims are limited to participants who are randomized into the factorial trial (estimated to be approximately 65% of the total sample). The primary aim is to determine the combination of additional intervention components that maximize dietary adherence from time of randomization to 6 months among participants with low early dietary adherence. A secondary outcome is percent of participants reaching 5% weight loss from baseline to 6 months.
Decision analysis for intervention value efficiency (DAIVE) will be the decision-making approach used to select the treatment components included in the final, optimized intervention. DAIVE uses a Bayesian factorial analysis of variance that maximizes the expected value of the outcome by evaluating the predicted value associated with all possible combinations of the components. DAIVE will be used maximize the expected value of both mean total weeks of dietary adherence from randomization to 6 months and proportion reaching 5% weight loss at 6 months.
研究の種類
介入
入学 (推定)
580
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Brooke T Nezami, PhD
- 電話番号：2 919-966-5852
- メール：bnezami@unc.edu
研究連絡先のバックアップ
- 名前：Karen E Hatley, MPH
- 電話番号：2 919-966-5852
- メール：keericks@email.unc.edu
研究場所
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27514
- University of North Carolina at Chapel Hill
-
主任研究者：
- Brooke T Nezami, PhD
-
コンタクト：
- Karen E Hatley, MPH
- 電話番号：2 919-966-5852
- メール：keericks@email.unc.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- BMI 25-50 kg/m2 at baseline
- Own a smartphone with an active data and text messaging plan
- English-speaking and writing
- Willing to be randomized to any of the additional treatment components
Exclusion Criteria:
- Lost 5% or more of body weight (and kept it off) in the last 3 months
- Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa)
- Current symptoms of alcohol or substance dependence
- Currently pregnant, pregnant within the past 6 months, currently breastfeeding, or planning to become pregnant within the next 6 months
- Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
- Hospitalization for depression or other psychiatric disorders within the past 12 months
- History of psychotic disorder or bipolar disorder
- Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
- Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), except individuals on a stable dose of SSRIs for 3 months
- Current use of bone acting medications (e.g., raloxifene, calcitonin, parathyroid hormone during the past year, PTH-analogues [e.g., teriparatide, abaloparatide], sclerostin inhibitors (romosozumbab), RANK ligand inhibitors (denosumab) or bisphosphonates during the last two years
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4)
- Report a health condition for which the program's dietary and physical activity recommendations would be unsafe, including hospitalization for heart failure, myocardial infarction or stroke in the past year, chronic kidney disease stage IV or V, liver failure or cirrhosis, chronic obstructive pulmonary disease on oxygen or requiring steroids, osteoporosis on medication, sarcopenia, history of fragility fractures, or dementia
- Other health problems that may influence the ability to walk for physical activity or be associated with unintentional weight change, including current cancer diagnosis, cancer treatment within the past 5 years or tuberculosis
- Previous surgical procedure for weight loss or planned weight loss surgery in the next year
- Another member of the household is a participant or staff member on this trial
- Ability to provide consent (4 items adapted from the UBACC [University of California, San Diego Brief Assessment of Capacity to Consent])
- Reason to suspect that the participant would not adhere to the study intervention
- Does not live in the United States
- Cannot have participated in a research study conducted by UNC Weight Research Program in the past 2 years
Individuals endorsing joint problems, current treatment for hypertension or hyperlipidemia, or osteoporosis diagnosis not on medication will be required to obtain written physician consent to participate.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Condition 1
Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
実験的：Condition 2
Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
|
|
実験的：Condition 3
Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
実験的：Condition 4
Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
|
|
実験的：Condition 5
Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
実験的：Condition 6
Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
|
|
実験的：Condition 7
Core + Switch to Simplified Diet Monitoring + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
実験的：Condition 8
Core + Switch to Simplified Diet Monitoring
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
|
|
実験的：Condition 9
Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
実験的：Condition 10
Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
|
|
実験的：Condition 11
Core with Standard Diet Monitoring + Goal Autonomy/Planning + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
実験的：Condition 12
Core with Standard Diet Monitoring + Goal Autonomy/Planning
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
|
|
実験的：Condition 13
Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
実験的：Condition 14
Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
|
|
実験的：Condition 15
Core with Standard Diet Monitoring + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
実験的：Condition 16
Core with Standard Diet Monitoring
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
|
|
他の：Core Only (Responders)
Core program (participants who are not randomized in the factorial intervention)
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total weeks of dietary goal adherence
時間枠：Time of randomization to 6 months
|
Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met ≥ 3 days/week (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal).
|
Time of randomization to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent of participants reaching >= 5% weight loss
時間枠：Baseline to 6 months
|
Scale weights at baseline and 6 months will be used to calculate, among nonresponders randomized into the factorial trial, percent weight change ( [(weight at 6 months - baseline weight) / baseline weight] × 100) and classify participants as achieving or not achieving at least 5% weight loss.
|
Baseline to 6 months
|
|
Total days of dietary goal adherence
時間枠：Time of randomization to 6 months
|
Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal).
|
Time of randomization to 6 months
|
|
Weight Change (kg)
時間枠：Baseline, 6 months
|
Estimated mean weight change in kg from baseline to 6 months among nonresponders randomized into the factorial trial.
More negative values of weight change indicate greater weight loss.
Weights will be objectively measured in light clothes, without shoes, on the digital smart scales in participants' homes.
|
Baseline, 6 months
|
|
Dietary intake
時間枠：Baseline, 3 months, 6 months
|
Diet will be assessed using the self-administered National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, a free, web-based tool for 24-hour recalls.
Participants will complete unscheduled recalls on a weekday and a weekend day at each timepoint.
Change in average total kcals/day will be calculated among nonresponders randomized into the factorial trial.
Changes are calculated as (average daily kcal at 3/6 months - average daily kcal at baseline).
|
Baseline, 3 months, 6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年3月1日
一次修了 (推定)
2029年9月1日
研究の完了 (推定)
2029年10月1日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月15日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-1211
- R01HL178992 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Deidentified individual data that supports the primary outcome results will be made available through the UNC Dataverse (https://dataverse.unc.edu/).
IPD 共有アクセス基準
The shared data will have a persistent unique identifier (DOI) from the UNC Dataverse repository.
The data will also be discoverable online through a standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。