Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 (M-TRIMM2)
Przegląd badań
Status
Warunki
Szczegółowy opis
The specific aims of this research project are to:
- Develop a targeted delivery system for mobile health messages which focused on improving physical activity and diet, and setting healthy resolutions each week.
- Deliver the M-TRIMM intervention, which encourages healthy behavior and the weekly renewal of health resolutions.
- Evaluate the effectiveness of this intervention on individuals' weight loss, self-efficacy, and motivation to sustain changes in lifestyle behaviors.
- Assess the benefit of receiving the message content only (in a paper document), versus a scheduled weekly delivery via mobile messaging.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- age ≥ 18 and <71
- BMI > 25
- having a phone that was capable of receiving text-messages and being willing to receive text-messages
Exclusion Criteria:
- age <18 or ≥ 71
- BMI ≤ 25
- not having a phone that was capable of receiving text-messages or not being willing to receive text-messages
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Intervention Group - Receiving Text Messages
The 16-weeks text-messaging intervention centered around 8 goal topics: eating only when hungry, increasing PA, eating a lower fat diet, eating less sugar and reducing calories from beverages, exercising more, eating a balance diet, portion control, and making healthier food choices in social situations. Messaging Sun evening: asked to pick 1 of 3 goal topics Mon morning: received a goal to focus on for the week Mon evening: asked whether plans were made to reach the goal Wed morning: received a tip to help reach goal Wed evening: reminded that if having cravings, text "tip" to automatically receive a tip Fri morning: received end of the week congratulations, encouragement to keep goals in mind over the weekend Fri evening: asked for weight, congratulated if lost weight, or encouraged if no weight lost |
see arm/group descriptions
After the baseline assessment and the 1st follow-up (~8 weeks post randomization), participants received educational materials regarding physical activity and healthier diets.
The study staff reviewed these materials with the participants
|
|
Aktywny komparator: Control Group - Written Messages
Participants in the control group, received a printed copy of the same messages that the intervention group received. However, the first eight-weeks' worth of messages and craving tips were given after the baseline assessment, and the rest were given after the first follow-up assessment (~ 8 weeks post randomization). The messages for each week were clearly laid out and labeled. Participants were given spaces to record their answers (i.e. to which goal they were selecting for each week). The study staff reviewed the first week's messages together with the study participants to get the participants comfortable with the format that the printed messages were presented in. |
After the baseline assessment and the 1st follow-up (~8 weeks post randomization), participants received educational materials regarding physical activity and healthier diets.
The study staff reviewed these materials with the participants
see arm/group descriptions
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Percent change in weight from baseline
Ramy czasowe: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
|
~8 weeks, ~16 weeks, and ~42 weeks post-randomization
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Body Mass Index (BMI) change from baseline
Ramy czasowe: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
|
BMI = kg/m2
|
~8 weeks, ~16 weeks, and ~42 weeks post-randomization
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline in self-efficacy to lose weight
Ramy czasowe: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
Weight Efficacy Lifestyle Questionnaire (Clark, Abrams,& Niaura, 1991)
|
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
|
Physical activity change from baseline
Ramy czasowe: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
International Physical Activity Questionnaire - was used to calculate the total metabolic equivalents (MET)-minutes per week, and MET-minutes per week for four domains of physical activity: (1) PA activity performed at work or during volunteer activities, (2) transportation-related PA (such as walking to do errands), (3) PA performed during housework and caring for family, and (4) recreational, sport, and leisure-time PA.
|
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
|
Change from baseline in fruit and vegetable servings intake from baseline
Ramy czasowe: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
National Cancer Institute's (NCI) 19-item All -Day Fruit and Vegetable Screener was used to calculate daily averages of fruit and vegetable serving intake, using NCI's 2001 scoring protocol.
|
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
|
Change from baseline in percent energy from fat intake
Ramy czasowe: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
National Cancer Institute's 17-item Percent Energy from Fat Screener - All-Day Quick Food Scan was used and scored according to NCI's 2004 protocol.
|
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
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Change from baseline in scores of perceived exercise benefits and barriers to engaging in exercise and physical activity
Ramy czasowe: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
The 43-item Exercise Benefits and Barriers Scale was used.
Separate scores will be calculated for perceived benefits and for perceived barriers.
(Sechrist, Walker, & Pender, 1987)
|
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
|
Comparison of satisfaction with the program and suggestions for improvement between intervention and control groups
Ramy czasowe: ~16 weeks, and ~42 weeks post-randomization compared to baseline
|
Participants completed a questionnaire that included quantitative and qualitative questions. Most of the qualitative questions sought to assess what parts of the program worked well and what could have been done better. For instance, participants were asked for their suggestions about what could be done to improve the M-TRIMM2 program, what messages they liked and did not like, and why they would or would not recommend the program to their friends. The quantitative questions covered a variety of topics, including participants engagement with the program (i.e. whether the participants read the messages they received), how useful messages were in helping participants reach the eight study goals (i.e. eating only when hungry, and exercising more), how helpful the goals were helping participants to achieve weight loss, and whether the program helped participants commit to new goals each Monday during the intervention. |
~16 weeks, and ~42 weeks post-randomization compared to baseline
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Lawrence Cheskin, MD, Johns Hopkins Bloomberg School of Public Health
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 00007115
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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